Dapivirine Monthly Vaginal Ring

Sponsor(s)

USAID https://www.usaid.gov/

Partnerships

	Ajinomoto OmniChem (Aji Bio-Pharma Services) https://ajibio-pharma.com/
	Nusil Technologies https://www.avantorsciences.com/pages/en/nusil
	QPharma https://www.qpharma.com/

Type of technology

Intra-vaginal ring

Administration route

Topical (Vaginal)

Development state and regulatory approval

Dapivirine (DPV)

Marketed

Positive scientific opinion from the European Medicines Agency for use among women ages 18 and older in developing countries. in WHO guidelines

Description

Silicone matrix vaginal ring delivering dapivirine over one month.

Technology highlight

The ring is made of a flexible silicone polymer and contains the ARV dapivirine, an NNRTI, which is dispersed in the silicone matrix and slowly released over the course of a month. The ring delivers dapivirine directly at the site of potential HIV infection, with low systemic absorption. Women insert the flexible, long-acting ring themselves into the vagina and replace it every month. EMA gave a CHMP scientific opinion under Article 58 / EU-M4all (23 July 2020). IPM withdrew the NDA from FDA in December 2021. WHO PQ (Nov 2020) . In 2025: extension of indication to women aged 16 and older. It is approved in 12 African countries.

Technology main components

Dapivirine 25 mg and silicone

Information on the raw materials sourcing, availability and anticipated price

9 to 13 USD/ring

Delivery device(s)

Silicone vaginal ring

API desired features

Small molecules

Dapivirine

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

< 10 wt%

API co-administration

1 single API : Still being investigated

LogP

Not provided
Dapivirine LogP = 5.6

Scale-up prospects

current scale: ~9000 rings future scale (2022 and beyond): ~45000 rings

Tentative equipment list for manufacturing

injection molding machine mixer automated inspection machine automated packaging machine

Manufacturing

GMP ISO class 8 area

Specific analytical instrument required for characterization of formulation

HPLC tensile tester dissolution apparatus analytical balance

ASPIRE

Identifier

NCT01617096

Link

https://clinicaltrials.gov/study/NCT01617096

Phase

Phase III

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Purpose

Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2012-07-24

Anticipated Date of Last Follow-up
2022-12-19

Estimated Primary Completion Date
2012-06-12

Estimated Completion Date
2012-06-12

Actual Primary Completion Date
2015-07-03

Actual Completion Date
2015-12-01

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Age 18 through 45 years (inclusive) at screening, verified per site SOPs; within this range, sites may restrict the upper age limit per site SOPs, to target women at high risk of HIV infection * Able and willing to provide written informed consent to be screened for and to take part in the study * Able and willing to provide adequate locator information, as defined in site SOPs * HIV-uninfected based on testing performed by study staff at screening and enrollment (per applicable algorithm in Appendix II) * Per participant report, sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening * Using an effective method of contraception at enrollment, and intending to use an effective method for the duration of study participat

Health status

Study type

Interventional (clinical trial)

Enrollment

2629

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 015

Identifier

NCT01071174

Link

https://clinicaltrials.gov/study/NCT01071174

Phase

Phase I/II

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.

Purpose

A Safety Study of Dapivirine Vaginal Ring in Africa

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2010-04-01

Anticipated Date of Last Follow-up
2011-08-01

Estimated Primary Completion Date
2010-02-19

Estimated Completion Date
2010-02-19

Actual Primary Completion Date
2011-05-01

Actual Completion Date
2011-07-01

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Women between 18 and 40 years of age inclusive who can provide informed consent * Available for all visits and consent to follow all procedures scheduled for the study * Healthy and self-reported sexually active * HIV-negative * On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment * In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses * Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator * Asymptomatic for genital infections at the time of enrolment * Willing to refrain from

Health status

Study type

Interventional (clinical trial)

Enrollment

280

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Triple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women

Identifier

NCT02808949

Link

https://clinicaltrials.gov/study/NCT02808949

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.

Purpose

Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2015-02-01

Anticipated Date of Last Follow-up
2018-03-12

Estimated Primary Completion Date
2016-06-22

Estimated Completion Date
2016-06-22

Actual Primary Completion Date
2018-03-03

Actual Completion Date
2018-03-03

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female

Accepts pregnant individuals
No

Accepts lactating individuals
Yes

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Women must meet all of the following criteria (by self-report, unless otherwise indicated) to be eligible for inclusion in the study: 1. Age 18 or older at screening as verified per site SOP 2. Per participant report, at least 6 weeks postpartum at Enrollment 3. Willing and able to provide written informed consent to be screened for and take part in the study 4. Willing and able to provide adequate locator information, as defined in site SOP 5. Willing and able to communicate in spoken and written English 6. HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results Note: HIV-1/2 screening may be omitted at Enrollment if the time between Screening and Enrollment is \< 30 days 7. Prior to Enrollment,

Health status

Study type

Interventional (clinical trial)

Enrollment

16

Allocation

Non-randomized

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

B-PROTECTED (MTN-043)

Identifier

NCT04140266

Link

https://clinicaltrials.gov/study/NCT04140266

Phase

Phase III

Status

Completed

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.

Purpose

Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-09-24

Anticipated Date of Last Follow-up
2023-07-14

Estimated Primary Completion Date
2019-10-25

Estimated Completion Date
2019-10-25

Actual Primary Completion Date
2021-11-04

Actual Completion Date
2021-11-04

Studied populations

Age Cohort

• Children
• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
Yes

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Inclusion Criteria - Mother Participant mothers must meet all the following criteria to be eligible for inclusion in the study: * Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs). * At Enrollment, between 6 to 12 weeks postpartum (verified by birth records and/or similar supportive documentation and defined as between 42 - 84 days after delivery, inclusive). * By participant report at Screening and Enrollment, currently exclusively breastfeeding one infant and willing and able to continue exclusively breastfeeding that infant for the duration of their participation in the study. * Note: Exclusive breastfeeding will be defined as infant nutrition solely from breast milk, as determined by 7-day recall breastfeeding histor

Health status

Study type

Interventional (clinical trial)

Enrollment

394

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

DELIVER (MTN-042)

Identifier

NCT03965923

Link

https://clinicaltrials.gov/study/NCT03965923

Phase

Phase III

Status

Completed

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

The purpose of this study is to evaluate the maternal and infant safety of the dapivirine (DPV) vaginal ring (VR) and daily oral Truvada in HIV-uninfected pregnant women and their infants.

Purpose

Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2020-01-09

Anticipated Date of Last Follow-up
2025-07-24

Estimated Primary Completion Date
2019-05-29

Estimated Completion Date
2019-05-29

Actual Primary Completion Date
2024-05-13

Actual Completion Date
2024-05-13

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
Yes

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Age 18 through 40 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs). * At Enrollment, evidence of a viable, intrauterine, singleton pregnancy with sonographic confirmation, including for gestational age assessment. * Note: If adequate (per judgment of Investigator of Record \[IoR\]/designee) sonographic results are not available from medical records at Screening, an ultrasound must be performed and results be available for review at Enrollment for all Cohorts. The ultrasound should be performed no later than the 36th week of gestation for Cohort 1 or the 28th week of gestation for Cohort 2. * At Enrollment, pregnancy within gestational age limits of the currently enrolling cohort (per the study protocol). * HIV-uninfected base

Health status

Study type

Interventional (clinical trial)

Enrollment

1104

Allocation

Randomized

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

MTN-025 (HOPE)

Identifier

NCT02858037

Link

https://clinicaltrials.gov/study/NCT02858037

Phase

Phase III

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

HIV Open-label Prevention Extension (HOPE).

Purpose

Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-07-18

Anticipated Date of Last Follow-up
2022-10-24

Estimated Primary Completion Date
2016-08-08

Estimated Completion Date
2016-08-08

Actual Primary Completion Date
2018-10-10

Actual Completion Date
2018-10-10

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Women must meet all of the following criteria to be eligible for inclusion in the study 1. Previously enrolled in MTN-020 (ASPIRE) 2. Able and willing to provide written informed consent to be screened for and to take part in the study 3. Able and willing to provide adequate locator information, as defined in site SOPs 4. HIV-uninfected based on testing performed by study staff at Screening and Enrollment 5. Using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs) 6. At Screening and Enrollment, agrees not to partic

Health status

Study type

Interventional (clinical trial)

Enrollment

1456

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to be replaced each month for a total period of 12 months of use.

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 027

Identifier

NCT01539226

Link

https://clinicaltrials.gov/study/NCT01539226

Phase

Phase III

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Purpose

Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2012-03-27

Anticipated Date of Last Follow-up
2022-09-26

Estimated Primary Completion Date
2012-02-27

Estimated Completion Date
2012-02-27

Actual Primary Completion Date
2016-12-13

Actual Completion Date
2016-12-13

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Women \> 18 and \< 45 years of age, at screening, who can provide informed consent; * Available for all visits and consent to follow all procedures scheduled for the trial; * Self-reported sexually active (defined as an average of at least one penetrative penile-vaginal coital act per month for the last 3 months prior to screening); * HIV-negative as determined by the HIV algorithm applied at screening and enrolment; * On a stable form of contraception as defined within section 5.4 and willing to continue on stable contraception for the duration of the clinical trial, unless post-menopausal or surgically sterilised; * Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant curable STI, she must have initia

Health status

Study type

Interventional (clinical trial)

Enrollment

1959

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

DREAM (IPM 032)

Identifier

NCT02862171

Link

https://clinicaltrials.gov/study/NCT02862171

Phase

Phase III

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women

Purpose

To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2016-07-12

Anticipated Date of Last Follow-up
2022-10-24

Estimated Primary Completion Date
2016-08-10

Estimated Completion Date
2016-08-10

Actual Primary Completion Date
2019-01-11

Actual Completion Date
2019-01-11

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Women must meet all the following criteria to be eligible to enrol in the trial: 1. Previously enrolled in the IPM 027 trial 2. Available for all visits and consent to follow all procedures scheduled for the trial 3. Using an effective method of contraception at the Enrolment Visit, and intending to use an effective contraceptive method for the duration of trial participation, unless post-menopausal with no history of menses for one year prior to screening 4. HIV-negative as determined by the HIV algorithm applied at Screening/Pre- Enrolment 5. Willing to refrain from participation in another research trial using drugs, vaccines, medical devices and microbicides for the duration of the IPM 032 trial 6. Willing to provide adequate locator information for trial retentio

Health status

Study type

Interventional (clinical trial)

Enrollment

941

Allocation

Not provided

Intervention model

Single group assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 018

Identifier

NCT00469768

Link

https://clinicaltrials.gov/ct2/show/NCT00469768

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

Not provided

Purpose

Evaluate the pharmacokinetics and safety of a 25 mg of Dapivirine intravaginal ring in HIV-uninfected women to determine the release of Dapivirine from the reservoir and matrix.

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2007-05-01

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2007-08-01

Actual Completion Date
2007-08-01

Studied populations

Age Cohort

• Adults

Genders

• Cisgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Women aged between 18-35 years.

Health status

Study type

Interventional (clinical trial)

Enrollment

24

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 001

Identifier

NCT00700284

Link

https://clinicaltrials.gov/ct2/show/NCT00700284

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

Not provided

Purpose

Evaluate the feasibility, safety and tolerability of utilising a vaginal ring delivery system to administer TMC120 (dapivirine).

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2004-10-01

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2005-01-01

Actual Completion Date
2005-01-01

Studied populations

Age Cohort

• Adults

Genders

• Cisgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Women aged between 18-50 years.

Health status

Study type

Interventional (clinical trial)

Enrollment

12

Allocation

Non-randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 054

Identifier

NCT05416021

Link

https://clinicaltrials.gov/study/NCT05416021

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants

Purpose

Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-08-01

Anticipated Date of Last Follow-up
2024-07-02

Estimated Primary Completion Date
2024-04-01

Estimated Completion Date
2024-04-01

Actual Primary Completion Date
2024-04-02

Actual Completion Date
2024-07-02

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 1. Assigned female sex at birth per participant report\* 2. Age 18 through 45 years (inclusive) at Screening, verified by national identification book/card 3. Able and willing to provide written informed consent to be screened for and enrolled in IPM 054 4. Able and willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures, eg, by home visit or telephone, or via family or close neighbour contacts (confidentiality to be maintained) 5. Able to complete a diary card 6. Available for all visits and able and willing to comply with all trial procedural requirements 7. Willing to comply with abstinence and other protocol requirements 8. Willing to use male condoms for penile-vaginal intercourse and penile-recta

Health status

Study type

Interventional (clinical trial)

Enrollment

124

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 034

Identifier

NCT01952561

Link

https://clinicaltrials.gov/ct2/show/NCT01952561

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

Not provided

Purpose

Evaluate the blood and vaginal pharmacokinetics of a 25mg Dapivirine vaginal ring worn for 1, 2, 4, 8 or 12 months.

Interventions

Intervention 1

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2013-11-01

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2014-03-01

Actual Completion Date
2014-05-01

Studied populations

Age Cohort

• Adults

Genders

• Cisgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Women between 18-40 years of age.

Health status

Study type

Interventional (clinical trial)

Enrollment

40

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

MTN-023/IPM 030

Identifier

NCT02028338

Link

https://clinicaltrials.gov/study/NCT02028338

Phase

Phase II

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.

Purpose

Study of Dapivirine Vaginal Ring (VR) in Adolescents

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2014-06-27

Anticipated Date of Last Follow-up
2022-09-26

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2016-07-05

Actual Completion Date
2018-06-08

Studied populations

Age Cohort

• Children

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 1. Age 15 through 17 years (inclusive) at Enrollment, verified per site SOPs 2. Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (as specified in site SOP) to be screened for and to enroll in MTN-023/IPM 030 3. Able and willing to provide adequate locator information, as defined in site SOPs 4. Able to communicate in spoken and written English 5. Able and willing to comply with all study procedural requirements 6. Per participant report at Screening and Enrollment, willing to abstain from inserting anything into the vagina for 72 hours prior to each follow-up visit, including abstaining from penile-vaginal intercourse. Note: In the event the vaginal ring has been expelled and requires reinsertion, re

Health status

Study type

Interventional (clinical trial)

Enrollment

96

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Quadruple-blind masking

Masking description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM024

Identifier

NCT02920827

Link

https://clinicaltrials.gov/study/NCT02920827

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

The proposed study is a single center, double-blind placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.

Purpose

Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2009-08-01

Anticipated Date of Last Follow-up
2017-09-05

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2010-04-01

Actual Completion Date
2010-04-01

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * were females between 18 and 40 years of age, inclusive * were willing and able to give written, informed consent * were available for all visits and consented to follow all procedures scheduled for the trial * were healthy, based on medical history, vital signs, physical examination, urinalysis (dipstick and microscopy), laboratory evaluations for genital infections (gonorrhea, chlamydia and trichomonas), and laboratory evaluations for hematology and biochemistry * were HIV-negative, as determined by an HIV test at screening * were willing to abstain from sexual activity for the duration of the period of ring use * were on a stable form of contraception, defined as a stable oral contraceptive regimen for at least two months prior to enrollment; OR a transdermal contr

Health status

Study type

Interventional (clinical trial)

Enrollment

16

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 013

Identifier

NCT01144676

Link

https://clinicaltrials.gov/ct2/show/NCT01144676

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

Not provided

Purpose

Evaluate the delivery of dapivirine from matrix intravaginal rings to assess the safety in comparison to placebo intravaginal rings in HIV-uninfected sexually active women.

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2010-04-01

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2010-09-01

Actual Completion Date
2010-09-01

Studied populations

Age Cohort

• Adults

Genders

• Cisgender female

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Women aged between 18-40 years.

Health status

Study type

Interventional (clinical trial)

Enrollment

45

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM008, TMC120-C131

Identifier

NCT00332995

Link

https://clinicaltrials.gov/study/NCT00332995

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women. Safety and tolerability will be assessed through clinical and laboratory assessments. Feasibility of drug delivery will be assessed by measuring dapivirine (TMC120) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.

Purpose

Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2005-07-01

Anticipated Date of Last Follow-up
2009-08-31

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2005-08-01

Actual Completion Date
2005-08-01

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Female, age 18-50 years * Willing and able to provide written informed consent * HIV-uninfected and otherwise healthy * Willing to abstain from sexual activity and from use of vaginal products while participating in the study * Currently using oral contraceptives for pregnancy prevention * Willing to use oral contraceptives as needed to avoid menstruation while taking part in this study Exclusion Criteria: * History of allergy to TMC120 or to the constituents of the vaginal ring * History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months * History of genital tract surgery within the last month * Currently pregnant or breastfeeding, or within two months of last pregnancy outcome * Currently or within one month of partic

Health status

Study type

Interventional (clinical trial)

Enrollment

13

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

MTN-036/IPM 047

Identifier

NCT03234400

Link

https://clinicaltrials.gov/study/NCT03234400

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.

Purpose

A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2017-12-04

Anticipated Date of Last Follow-up
2019-01-25

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2018-10-23

Actual Completion Date
2019-01-23

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Assigned female sex at birth Note: Participants who are female at birth, who now identify as male, will not be excluded so long as they are not on female-to-male transition therapy. * Age 18 through 45 years (inclusive) at Screening, verified per site SOPs * Able and willing to provide written informed consent to be screened for and enrolled in MTN-036/IPM 047 * Able and willing to provide adequate locator information, as defined in site SOPs * Able to communicate in spoken and written English * Available for all visits and able and willing to comply with all study procedural requirements * Willing to comply with abstinence and other protocol requirements * Willing to use male condoms for penile-vaginal intercourse (PVI) and penile-rectal intercourse for the duration

Health status

Study type

Interventional (clinical trial)

Enrollment

49

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Single blind masking

Masking description

Single (Participant)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 009B

Identifier

NCT01337583

Link

https://clinicaltrials.gov/study/NCT01337583

Phase

Phase III

Status

Withdrawn

Sponsor

International Partnership for Microbicides, Inc.

More details

This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.

Purpose

A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2011-07-01

Anticipated Date of Last Follow-up
2012-06-08

Estimated Primary Completion Date
2014-07-01

Estimated Completion Date
2014-07-01

Actual Primary Completion Date
2014-07-01

Actual Completion Date
2014-07-01

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Women \>18 and \<40 years of age who can provide informed consent * Available for all visits and consent to follow all procedures scheduled for the trial * Generally healthy and self-reported sexually active (defined as an average of at least one penetrative penile vaginal coital act per month for the last 3 months prior to enrolment) * HIV-negative as determined by the HIV algorithm applied at screening and enrolment * On a stable form of contraception and willing to continue on stable contraception for the duration of the clinical trial; * Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant treatable STI, she must have initiated treatment at least 1 week prior to enrolment and have completed the full

Health status

Study type

Interventional (clinical trial)

Enrollment

Not provided

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

MTN-034

Identifier

NCT03593655

Link

https://clinicaltrials.gov/study/NCT03593655

Phase

Phase II

Status

Completed

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

More details

The purpose of this study is to evaluate the safety of and adherence to a vaginal matrix ring (VR) containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in adolescent and young adult females.

Purpose

Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2019-01-14

Anticipated Date of Last Follow-up
2023-06-20

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2021-09-09

Actual Completion Date
2021-09-09

Studied populations

Age Cohort

• Children
• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Age 16 through 21 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs). * Able and willing to provide informed consent, and if under the legal age of consent be able to provide informed assent and obtain parental or guardian permission/consent, to be screened for and to enroll in MTN-034 (as specified in site SOP). * Able and willing to provide adequate locator information, as defined in site SOPs. * Able and willing to comply with all study procedural requirements. * Per participant report at Screening, post-menarche. * HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithms found in the study protocol). * Per participant report at Screening, history of at least one episode of sexual intercour

Health status

Study type

Interventional (clinical trial)

Enrollment

247

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

IPM 035

Identifier

NCT02858024

Link

https://clinicaltrials.gov/study/NCT02858024

Phase

Phase I

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine

Purpose

A Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Intervention 5

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2015-01-12

Anticipated Date of Last Follow-up
2017-09-05

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2016-04-16

Actual Completion Date
2016-04-16

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Participants must meet all the following criteria to be eligible to enroll in the trial: 1. Women 18 and ≤ 40 years of age who can give written informed consent; 2. Available for all visits and consent to follow all procedures scheduled for the trial; 3. Healthy, based on medical history, vital signs, physical examination, urinalysis (dipstick and microscopy \[if indicated\]), laboratory evaluations for genital infections (bacterial vaginosis, gonorrhoea, chlamydia, and trichomonas), and laboratory evaluations for haematology and biochemistry; 4. HIV-negative as determined by an HIV test at screening; 5. On a stable oral contraceptive regimen for at least three months prior to screening; 6. Upon pelvic examination at the time of enrollment, the cervix and vagina appea

Health status

Study type

Interventional (clinical trial)

Enrollment

16

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

None (Open Label)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

MTN-024/IPM031

Identifier

NCT02010593

Link

https://clinicaltrials.gov/study/NCT02010593

Phase

Phase II

Status

Completed

Sponsor

International Partnership for Microbicides, Inc.

More details

This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.

Purpose

Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2013-12-01

Anticipated Date of Last Follow-up
2022-11-02

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2015-04-01

Actual Completion Date
2015-04-01

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• Female
• Cisgender female
• Transgender male

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 1. Age 45 through 65 years (inclusive) at Screening, verified per site SOPs 2. Per participant report, postmenopausal at Screening, defined as amenorrhoeic for the past 12 months (minimum) or at least 6 months status post-bilateral oophorectomy 3. Follicle-stimulating hormone (FSH) level at 40 mIU/ml or higher at Screening 4. Able and willing to provide written informed consent to be screened for and enrolled in MTN-024/IPM 031 5. Able to communicate in spoken and written English 6. Able and willing to comply with all study procedural requirements 7. Willing to only use study provided and/or approved vaginal products throughout the duration of study participation. 8. Willing to abstain from inserting study approved lubricant into the vagina for 72 hours prior to each v

Health status

Study type

Interventional (clinical trial)

Enrollment

96

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Double (Participant, Investigator)

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Indication(s)

HIV

Key resources

Proprietary excipients used

silicone elastomer for extended use

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

excipient has been included in regulatory dossier for product

Residual solvents used

No residual solvent used

Other features of the technology

• Drug-eluting
• Removable
• Molded
• Room temperature storage
• At least 1 year shelf life

Release properties

Releases dapivirine over a one-month period

Injectability

Not Applicable

Stability

ICH Climate Zone IV (A/B)

Storage conditions and cold-chain related features

5 years shelf life This product does not require specific temperature storage conditions. Store in the original package to protect from light.

Safety

There were no safety concerns with long-term use of the ring in Phase III clinical studies. Data from two open-label (Phase IIIB) studies show a similar favorable safety profile as do 12 smaller safety studies.

Efficacy

Not provided

Evidence Summary

Not provided

Therapeutic area(s)

Use case(s)

Use of technology

Technology patent families

Not patent applicable for this technology

Dapivirine 25 mg (vaginal ring)

Publications

Evaluating the potential impact and cost-effectiveness of dapivirine vaginal ring pre-exposure prophylaxis for HIV prevention. 

Reidy M, Gardiner E, Pretorius C, Glaubius R, Torjesen K, Kripke K. 

PLoS One. 2019;14(6):e0218710. 

Published 2019 Jun 26. doi:10.1371/journal.pone.0218710

Background
Expanded HIV prevention options are needed to increase uptake of HIV prevention among women, especially in generalized epidemics. As the dapivirine vaginal ring moves forward through regulatory review and open-label extension studies, the potential public health impact and cost-effectiveness of this new prevention method are not fully known. We used mathematical modeling to explore the impact and cost-effectiveness of the ring in different implementation scenarios alongside scale-up of other HIV prevention interventions. Given the knowledge gaps about key factors influencing the ring’s implementation, including potential uptake and delivery costs, we engaged in a stakeholder consultation process to elicit plausible parameter ranges and explored scenarios to identify the possible range of impact, cost, and cost-effectiveness.

Methods and findings
We used the Goals model to simulate scenarios of oral and ring pre-exposure prophylaxis (PrEP) implementation among female sex workers and among other women ≤21 years or >21 years with multiple male partners, in Kenya, South Africa, Uganda, and Zimbabwe. In these scenarios, we varied antiretroviral therapy (ART) coverage, dapivirine ring coverage and ring effectiveness (encompassing efficacy and adherence) by risk group. Following discussions with stakeholders, the maximum level of PrEP coverage (oral and/or ring) considered in each country was equal to modern contraception use minus condom use in the two age groups.

We assessed results for 18 years, from 2018 to 2035. In South Africa, for example, the HIV infections averted by PrEP (ring plus oral PrEP) ranged from 310,000 under the highest-impact scenario (including ART held constant at 2017 levels, high ring coverage, and 85% ring effectiveness) to 55,000 under the lowest-impact scenario (including ART reaching the UNAIDS 90-90-90 targets by 2020, low ring coverage, and 30% ring effectiveness). This represented a range of 6.4% to 2.2% of new HIV infections averted. Given our assumptions, the addition of the ring results in 11% to 132% more impact than oral PrEP alone. The cost per HIV infection averted for the ring ranged from US$13,000 to US$121,000.

Conclusions
This analysis offers a wide range of scenarios given the considerable uncertainty over ring uptake, consistency of use, and effectiveness, as well as HIV testing, prevention, and treatment use over the next two decades. This could help inform donors and implementers as they decide where to allocate resources in order to maximize the impact of the dapivirine ring in light of funding and implementation constraints. Better understanding of the cost and potential uptake of the intervention would improve our ability to estimate its cost-effectiveness and assess where it can have the most impact.

Safety , adherence , and HIV-1 seroconversion among women using the dapivirine vaginal ring ( DREAM ): an open-label , extension study. 

Nel A, Niekerk N Van, Baelen B Van, et al. 

Lancet HIV. 2021;8:77-86. doi:10.1016/S2352-3018(20)30300-3

Link: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(20)30300-3/fulltext

Additional documents

• Ring resources

• IPM Ring Backgrounder

Useful links

• Presentation of dapivirine monthly ring

• MTN-034 (REACH) Phase 2a

• MTN-042 (Deliver) Phase 3b

• MTN-043 (B-Protected) Phase 3b

• Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial

• Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa

• Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

• Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study

• Acquisition of Sexually Transmitted Infections among Women Using a Variety of Contraceptive Options: A prospective Study among High-risk African Women

• Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring

• Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE

• Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

• Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa

• Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial

• Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

• Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring

• Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE

• Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women Using the Dapivirine Vaginal Ring

• Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

• Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV

• Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

• Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda

• Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study

• Outline Images Download Cite Share Favorites Permissions PREVENTION RESEARCH Brief Report: Phase IIa Safety Study of a Vaginal Ring Containing Dapivirine in Adolescent Young Women

• Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States

• Users' Preferred Characteristics of Vaginal Rings for HIV Prevention: A Qualitative Analysis of Two Phase I Trials

• Acceptability of the Dapivirine Vaginal Ring in Postmenopausal US Women

• Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women