Clinical trials
160018
Identifier
NCT02599896
Link
https://clinicaltrials.gov/study/NCT02599896
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
Background:
Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses. Researchers want to see if it does this in people.
Objectives:
To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is maintained in people and if they develop an immune response to it.
Eligibility:
Healthy people ages 18 to 50
Design:
Participants will be screened in protocol number VRC 500 (NIH 11-I-0164) with medical history, physical exam, and blood and urine tests.
The study will last 24 to 48 weeks. Visits will last 2 to 8 hours.
Participants will get VRC01LS through either:
* A needle in an arm vein or
* A small needle placed into the fatty tissue un
Purpose
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults
Interventions
Intervention 1
VRC-HIVMAB080-00-AB (VRC01LS)
Intervention 2
VRC-HIVMAB060-00-AB (VRC01)
Countries
Botswana
Brazil
Malawi
Zimbabwe
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-11-16
Anticipated Date of Last Follow-up
2019-12-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2018-07-25
Actual Completion Date
2018-07-25
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
* INCLUSION CRITERIA:
A volunteer must meet all of the following criteria:
1. Able and willing to complete the informed consent process.
2. 18 to 50 years of age.
3. Based on history and examination, must be in general good health without history of any of the conditions listed in the exclusion criteria.
4. Willing to have blood samples collected, stored indefinitely, and used for research purposes.
5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
6. Screening laboratory values within 84 days prior to enrollment must meet the following criteria:
* WBC 2,500-12,000/mm(3).
* WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
* Platelets
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
49
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other/Variable/Unknown
:
"Every 2 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Intravenous
Use case
Treatment
Key resources
Not provided
IMPAACT 2008
Identifier
NCT03208231
Link
https://clinicaltrials.gov/study/NCT03208231
Phase
Phase I/II
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).
Purpose
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
Interventions
Intervention 1
VRC01
Dosage: 40 mg/kg
Intervention 2
Combination Antiretroviral Therapy (cART)
Countries
Botswana
Brazil
Malawi
Zimbabwe
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-08-06
Anticipated Date of Last Follow-up
2023-04-27
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-06-16
Actual Completion Date
2021-02-11
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Infant Inclusion Criteria:
* Weigh at least 2500 grams
* Confirmed HIV-1 infection
* The following laboratory values at screening:
* Cluster of differentiation 4 (CD4) lymphocyte percentage greater than 15
* Severity grade 1 or lower hemoglobin, platelet count, and absolute neutrophil count
* Severity grade 1 or lower alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase
* First dose of initial combination antiretroviral therapy (cART) regimen taken on the day of randomization or within 14 days prior to the day of randomization
* Expected to be available for 48 weeks of follow-up at study entry
* Parent or legal guardian willing and able to provide written informed consent for infant participation in the study
* Parent or legal guardian willing
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
61
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other/Variable/Unknown
:
"Q2W
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
Tatelo Study
Identifier
NCT03707977
Link
https://clinicaltrials.gov/study/NCT03707977
Phase
Phase I/II
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.
Purpose
Dual bNAb Treatment in Children
Interventions
Intervention 1
ART
Intervention 2
VRC01LS
Intervention 3
10-1074
Countries
Botswana
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-06-17
Anticipated Date of Last Follow-up
2024-09-30
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-12-03
Actual Completion Date
2021-12-03
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria for PK Step\*:
* On ART for at least 96 weeks
* Greater than or equal to 96 weeks and less than 5 years of age at enrollment
* HIV RNA less than 40 copies/mL for at least 24 weeks prior to entry
* Ability to remain in close study follow-up for at least 12 weeks
* Willingness to receive IV infusions of bNAbs
* Willingness to provide signed informed consent (by the parent/guardian)
* \*It is anticipated that all children in PK Step will be from Early Infant Treatment (EIT) Study (NCT02369406); however, up to 4 HIV+ children outside the PK Study (age range 2-5 years) may participate in the PK Step if otherwise eligible and if EIT children are unavailable.
Inclusion Criteria for Entry into Step 1 (followed by participation in Steps 2-3):
* EIT Study participant (NCT023
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
30
Allocation
Not provided
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
RV 397
Identifier
NCT02664415
Link
https://clinicaltrials.gov/study/NCT02664415
Phase
Phase II
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.
Purpose
Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
Interventions
Intervention 1
VRC01
Intervention 2
Placebo for VRC01
Countries
Thailand
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-08-01
Anticipated Date of Last Follow-up
2021-10-29
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-08-04
Actual Completion Date
2017-08-04
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Able and willing to provide written informed consent or, in the case of illiteracy, witnessed verbal informed consent with documentation of a thumbprint in lieu of a signature.
* Passes Test of Understanding.
* Man or woman aged 20-50 years.
* Initiated on ART during acute HIV infection (Fiebig Stage I to III at RV 254 enrollment).
* Prescribed ART for at least 24 months prior to enrollment.
* HIV-1 RNA less than 50 copies/mL on at least three consecutive measurements within the past 12 months.
* Integrated HIV DNA in peripheral blood mononuclear cells (PBMCs) below the level of detection (1 copy/10\^5 PBMCs) within 6 months prior to enrollment.
* Last documented peripheral blood CD4 greater than 400 cells/mm\^3 within 3 months prior to enrollment.
* No HIV-related o
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
23
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Other/Variable/Unknown
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
HVTN 804/HPTN 095
Identifier
NCT04801758
Link
https://clinicaltrials.gov/study/NCT04801758
Phase
Not provided
Status
Completed
Sponsor
HIV Vaccine Trials Network
More details
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if they get HIV. This study will evaluate the viral and immune system responses in an Analytical Treatment Interruption (ATI), in participants who received VRC01 or placebo and got HIV while enrolled in HVTN 704/HPTN 085 (NCT02716675).
Participants in this study will stop taking their HIV medication. They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section "Detailed Description". While they are not taking HIV medication, the
Purpose
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study
Interventions
Intervention 1
Analytical Treatment Interruption
Countries
Brazil
Peru
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-08-22
Anticipated Date of Last Follow-up
2025-04-18
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2024-07-22
Actual Completion Date
2024-07-22
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Estimated date of HIV-1 acquisition within 8 weeks of participant's last HVTN 704/HPTN 085 infusion.
* Initiated ART within 28 weeks of HVTN 704/HPTN 085 HIV-1 date of diagnosis.
* Receiving continuous ART for at least 1 year. ART interruptions of up to 7 days and ≥ 90 days prior to enrollment are acceptable. Within- and between-class changes in ART within the previous year are acceptable.
* If on an NNRTI, willingness and ability to switch to a PI- or INSTI-containing regimen for at least 4 weeks prior to ART interruption.
* Willingness to interrupt ART for up to 24 weeks or up to the time of meeting ART re-initiation criteria.
* Willingness to re-initiate ART upon meeting study ART re-initiation criteria.
* Willingness to use barrier protection (ie, male or female
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
18
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Not provided
Use case
Treatment
Key resources
Not provided
HVTN 805/HPTN 093
Identifier
NCT04860323
Link
https://clinicaltrials.gov/study/NCT04860323
Phase
Not provided
Status
Not provided
Sponsor
HIV Vaccine Trials Network
More details
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if they get HIV. This study will evaluate the viral and immune system responses in an Analytical Treatment Interruption (ATI), in participants who received VRC01 or placebo and got HIV while enrolled in HVTN 703/HPTN 081 (NCT02568215).
Participants in this study will stop taking their HIV medication. They will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is unable to control the HIV or they meet other ART re-start criteria as noted in section "Detailed Description". While they are not taking HIV medication, the
Purpose
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study
Interventions
Intervention 1
Analytical Treatment Interruption
Countries
Botswana
Malawi
South Africa
Zimbabwe
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-05-28
Anticipated Date of Last Follow-up
2024-08-07
Estimated Primary Completion Date
2025-02-28
Estimated Completion Date
2025-02-28
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Estimated date of HIV-1 acquisition within 8 weeks (ie, before or after) having received an HVTN 703/HPTN 081 infusion.
* Initiated ART within 28 weeks of HVTN 703/HPTN 081 date of HIV-1 diagnosis.
* Receiving continuous ART for at least 1 year. ART interruptions of up to 7 days in duration and ≥ 90 days prior to enrollment are acceptable. Within- and between-class changes in ART within the previous year are acceptable.
* If on an NNRTI, willingness and ability to switch to a PI- or INSTI-containing regimen for at least 4 weeks prior to ART interruption.
* Willingness to interrupt ART for up to 24 weeks or up to the time of meeting ART re-initiation criteria.
* Willingness to re-initiate ART upon meeting study ART re-initiation criteria.
* Willingness to use barrier
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
13
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Weekly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Not provided
Use case
Treatment
Key resources
Not provided
HVTN 704/HPTN 085
Identifier
NCT02716675
Link
https://clinicaltrials.gov/study/NCT02716675
Phase
Phase II
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.
Purpose
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men
Interventions
Not provided
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-04-06
Anticipated Date of Last Follow-up
2022-02-08
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-12-01
Actual Completion Date
2020-12-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
General and Demographic Criteria
* Age of 18 to 50 years
* Access to a participating clinical research site (CRS) and willingness to be followed for the planned duration of the study
* Ability and willingness to provide informed consent
* Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first infusion with verbal demonstration of understanding of all questionnaire items answered incorrectly
* Agrees not to enroll in another study of an investigational research agent for the duration of the participant's trial participation
* Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria
* Willingness to receive HIV test results
* Willingness to
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
2699
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Every 2 months
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
PrEP
Key resources
Not provided
HVTN 703/HPTN 081
Identifier
NCT02568215
Link
https://clinicaltrials.gov/study/NCT02568215
Phase
Phase II
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
Purpose
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
Interventions
Intervention 1
VRC01
Intervention 2
Placebo for VRC01
Countries
Botswana
Kenya
Malawi
Mozambique
South Africa
Tanzania, United Republic of
Zimbabwe
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-05-01
Anticipated Date of Last Follow-up
2022-02-08
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-03-03
Actual Completion Date
2021-03-03
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
General and Demographic Criteria
* Age of 18 to 50 years
* Access to a participating clinical research site (CRS) and willingness to be followed for the planned duration of the study
* Ability and willingness to provide informed consent
* Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first infusion with verbal demonstration of understanding of all questionnaire items answered incorrectly
* Agrees not to enroll in another study of an investigational research agent for the duration of the participant's trial participation
* Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria
* Willingness to receive HIV test results
* Willingness to
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
1924
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Every 2 months
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
PrEP
Key resources
Not provided
17-23507
Identifier
NCT03729752
Link
https://clinicaltrials.gov/study/NCT03729752
Phase
Phase I
Status
Recruiting
Sponsor
University of California, San Francisco
More details
This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR imaging in HIV infected individuals and healthy volunteers. Imaging data will be obtained from up to four static PE-MR images in order to determine dosimetry and temporal tissue uptake/tissue distribution of 89Zr-DFO-VRC01. This is not a treatment study of the biological activity of 89Zr-DFO-VRC01 to impact HIV persistence.
Purpose
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
Interventions
Intervention 1
[89]Zr-DFO-VRC-HIVMAB060-00-AB
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-11-01
Anticipated Date of Last Follow-up
2023-08-09
Estimated Primary Completion Date
2024-10-31
Estimated Completion Date
2025-01-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
Study Phase 1
1. Age ≥18 years, and
2. HIV uninfected, or
3. HIV infection, and
4. has an HIV viral load measurement within 12 months of study entry of \>40 copies/mL, and
5. HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activity (HIV infected participants only)
Study Phase 2
1. Age ≥18 years, and
2. HIV infection, and
3. Initiated a combination ART regimen and has HIV viral load measurements below the detection limit of a clinically approved PCR-based assay (e.g. \<40 HIV-1 RNA copies/mL of blood), or
4. HIV infection, and
5. has an HIV viral load measurement within 12 months of study entry of \>40 copies/mL, and
6. HIV-1 envelope RNA or DNA consensus sequence from peripheral blood suggestive of VRC01 binding activit
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
30
Allocation
Not provided
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Unspecified
Key resources
Not provided
A5340
Identifier
NCT02463227
Link
https://clinicaltrials.gov/study/NCT02463227
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of an antibody (called VRC01) in HIV-infected adults whose HIV was well-controlled with HIV medicines. The study examined whether VRC01 controlled or delayed the return of HIV viremia when the participants' HIV medicines were briefly stopped during the study.
Purpose
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption
Interventions
Intervention 1
VRC01
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-08-01
Anticipated Date of Last Follow-up
2021-10-15
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2016-03-01
Actual Completion Date
2016-10-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Step 1 Inclusion Criteria:
* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load (VL). More information on this criterion can be found in the protocol.
* Ability and willingness of participant or legal representative to provide informed consent
* Clinically stable on their first or second ART regimen that includes a boosted protease inhibitor or an integrase inhibitor. The current regimen should have been stable for 8 weeks at the time of entry. Changes while the patient HIV viral load was undetectable did not coun
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
14
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
IMPAACT 2008
Identifier
NCT03208231
Link
https://clinicaltrials.gov/study/NCT03208231
Phase
Phase I/II
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).
Purpose
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
Interventions
Intervention 1
VRC01
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-08-06
Anticipated Date of Last Follow-up
2023-04-27
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-06-16
Actual Completion Date
2021-02-11
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Infant Inclusion Criteria:
* Weigh at least 2500 grams
* Confirmed HIV-1 infection
* The following laboratory values at screening:
* Cluster of differentiation 4 (CD4) lymphocyte percentage greater than 15
* Severity grade 1 or lower hemoglobin, platelet count, and absolute neutrophil count
* Severity grade 1 or lower alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase
* First dose of initial combination antiretroviral therapy (cART) regimen taken on the day of randomization or within 14 days prior to the day of randomization
* Expected to be available for 48 weeks of follow-up at study entry
* Parent or legal guardian willing and able to provide written informed consent for infant participation in the study
* Parent or legal guardian willing
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
61
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Not provided
Key resources
Not provided
HVTN 116
Identifier
NCT02797171
Link
https://clinicaltrials.gov/study/NCT02797171
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults.
Purpose
Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults
Interventions
Intervention 1
VRC01
Intervention 2
VRC01LS
Countries
United States of America
South Africa
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2017-03-01
Anticipated Date of Last Follow-up
2024-02-19
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2019-06-05
Actual Completion Date
2019-06-05
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
General and Demographic Criteria:
* Age of 18 to 50 years
* Weight less than or equal to 115 kg
* Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
* Ability and willingness to provide informed consent
* Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly
* Agrees not to enroll in another study of an investigational research agent until completion of the last study visit
* Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
* Willing
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
80
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other/Variable/Unknown
:
"Two monthly
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
HVTN 104
Identifier
NCT02165267
Link
https://clinicaltrials.gov/study/NCT02165267
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
Antibodies are natural proteins that the body makes to fight infections. Antibodies can also be manufactured like a drug and infused or injected into the body to prevent or treat a disease. The purpose of this study is to test the safety of and the body's response to an antibody against HIV in healthy, HIV-uninfected adults.
Purpose
Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults
Interventions
Intervention 1
VRC01
Intervention 2
SC placebo for VRC01
Intervention 3
IV placebo for VRC01
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2014-08-01
Anticipated Date of Last Follow-up
2021-10-13
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2016-02-01
Actual Completion Date
2016-02-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
General and Demographic Criteria
* Weight at least 53 kg and up to 115 kg
* Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
* Ability and willingness to provide informed consent
* Assessment of understanding: participant demonstrates understanding of this study; completes a questionnaire prior to first infusion, with verbal demonstration of understanding of all questionnaire items answered incorrectly
* Agrees not to enroll in another study of an investigational research agent until completion of the last study visit
* Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria
* Willingness to receive
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
88
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Monthly
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
ACTG A5342
Identifier
NCT02411539
Link
https://clinicaltrials.gov/study/NCT02411539
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).
Purpose
Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)
Interventions
Intervention 1
VRC01
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-08-25
Anticipated Date of Last Follow-up
2021-11-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2016-04-15
Actual Completion Date
2016-09-29
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV or E/CIA tests, or by HIV-1 antigen, or plasma HIV-1 RNA assay. More information on this criterion is available in the protocol.
* Received continuous ART for at least 2 years (defined as no interruptions longer than 14 consecutive days) and with no changes in the components of the ART for at least 90 days prior to study entry
* CD4+ cell count greater than or equal to 200 cells/mm\^3 obtained within 60 days prior to study entry in a clinical laboratory improvement amendments (CLIA)-certified laborat
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
40
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Other/Variable/Unknown
:
"once every 3 weeks
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
RV 398
Identifier
NCT02591420
Link
https://clinicaltrials.gov/study/NCT02591420
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.
Purpose
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
Interventions
Intervention 1
VRC01
Intervention 2
Placebo for VRC01
Intervention 3
Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
Countries
Kenya
Tanzania, United Republic of
Thailand
Uganda
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2016-04-01
Anticipated Date of Last Follow-up
2021-11-23
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-03-15
Actual Completion Date
2021-03-15
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Inclusion Criteria:
* Able and willing to complete the informed consent process
* Passes Test of Understanding
* 18 to 50 years of age
* Experiencing early acute HIV-1 infection as defined by blood samples on at least two separate days positive by nucleic acid testing within 21 days of a negative nucleic acid HIV-1 test OR by a positive nucleic acid test or a positive 4th generation enzyme immunoassay (EIA) in the context of a negative 2nd or negative 3rd generation HIV EIA test
* No history of antiretroviral therapy for any indication in the last 30 days.
* In general good health
* Willing to have blood samples collected and stored
* Able to participate for 25 weeks for study visits
* Willing to have photo or fingerprint taken for identification purposes
Female-Specific Criteria:
* Agr
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
24
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
130189
Identifier
NCT01950325
Link
https://clinicaltrials.gov/study/NCT01950325
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody. VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and how long VRC01 can be detected in the blood after it is given.
Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/k
Purpose
VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administer
Interventions
Intervention 1
VRC-HIVMAB060-00-AB
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2013-08-22
Anticipated Date of Last Follow-up
2019-12-14
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2015-08-20
Actual Completion Date
2015-08-20
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
* INCLUSION CRITERIA:
A volunteer must meet all of the following criteria:
1. Able and willing to complete the informed consent process.
2. 18-60 years old during the dose escalation; 18-70 years old during subsequent enrollment of viremic subjects.
3. HIV infected and clinically stable,Volunteers during the dose escalation part of the study also must be, without changes in ARV status (whether or not taking an ARV regimen) in the 24 weeks prior to enrollment.
4. Criteria for volunteers enrolling during the dose escalation part of the study:
Plasma viral load (VL) and CD4 count that meet eligibility criteria on at least two measurements performed within the 24 weeks prior to enrollment. The two measurements used for eligibility must have at least 3 days between tests and at least one
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
27
Allocation
Not provided
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
150140
Identifier
NCT02471326
Link
https://clinicaltrials.gov/study/NCT02471326
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
Background:
- A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV levels when a person is off cART.
Objective:
- To see if the new product VRC01 is safe and can control the HIV level in the blood when a person is not taking cART.
Eligibility:
- Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24 weeks.
Design:
* Participants will be screened with:
* Physical exam
* Medical history
* Heart tests
* Blood and urine tests.
* Their HIV drugs may be switched. They will keep taking them until a few days after Visit 1.
* Visit 1: R
Purpose
VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption
Interventions
Intervention 1
VRC-HIVMAB060-00-AB (VRC01)
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-07-13
Anticipated Date of Last Follow-up
2017-10-02
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2017-04-07
Actual Completion Date
2017-04-07
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
* INCLUSION CRITERIA
1. Age 18-65 years old.
2. HIV-1 infection and clinically stable.
3. In general good health and with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider for medical management of HIV infection while participating in the study.
4. CD4+ cell count \>450 cells/mm\^3 at screening.
5. Documentation of continuous cART treatment with suppression of plasma viral level below the limit of detection for greater than or equal to 3 years. Subjects with blips (i.e., detectable viral levels on cART) prior to screening may be included provided they satisfy the following criteria:
1. The blips are \<400 copies/mL, and
2. Succeeding viral levels return to level
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
10
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
190048
Identifier
NCT03831945
Link
https://clinicaltrials.gov/study/NCT03831945
Phase
Phase I
Status
Terminated
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
Background:
A daily drug combination can keep human immunodeficiency virus (HIV) levels low for a long time. But if this combination antiretroviral therapy (ART) stops, HIV levels go back up. People can also develop resistance or permanent side effects. Researchers want to see if 2 new drugs can help control HIV when a person is not on ART.
Objective:
To see if VRC01 and 10-1074 are safe and control HIV when a person is not on ART.
Eligibility:
Adults 18-65 with HIV
Design:
All participants must agree to practice safer sex. Those who can get pregnant will have a pregnancy test every visit.
Participants will be screened with:
Physical exam
Medicine review
Blood and urine tests
Some participants may need to change their HIV medicine for a brief period of time during the study.
A
Purpose
Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions
Interventions
Intervention 1
VRC-HIVMAB060-00-AB (VRC01)
Intervention 2
10-1074
Intervention 3
Normal Saline Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-04-04
Anticipated Date of Last Follow-up
2021-09-22
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-12-08
Actual Completion Date
2020-12-08
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
* INCLUSION CRITERIA:
1. 18-65 years of age.
2. HIV-1 infection and clinically stable.
3. General good health and has an identified primary health care provider for medical management of HIV infection and is willing to maintain a relationship with a primary health care provider for medical management of HIV infection while participating in the study.
4. CD4+ T cell count \>450 cells/mm(3) at screening.
5. Documentation of continuous ART treatment with suppression of plasma viral level below the lower limit of quantification (LLOQ) for the assay used for greater than or equal to 2 years. Individuals with blips (i.e., detectable viral levels on ART) prior to screening may be included provided they satisfy the following criteria:
1. The blips are \<400 copies/mL, and
2.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
27
Allocation
Randomized
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
IMPAACT P1112
Identifier
NCT02256631
Link
https://clinicaltrials.gov/study/NCT02256631
Phase
Phase I
Status
Completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
Purpose
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Interventions
Intervention 1
VRC01
Intervention 2
VRC01LS
Intervention 3
VRC07-523LS
Countries
United States of America
Puerto Rico
South Africa
Zimbabwe
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2015-06-30
Anticipated Date of Last Follow-up
2023-01-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2020-06-17
Actual Completion Date
2021-12-16
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Maternal Inclusion Criteria:
* HIV infection
* Greater than or equal to 18 years of age
* Able and willing to provide signed informed consent for herself and her infant
Maternal Exclusion Criteria:
* Prior participation in any HIV-1 vaccine trial
* Receipt of any other active or passive HIV immunotherapy or investigational product during this pregnancy. (Note that administration of Food and Drug Administration \[FDA\]-approved antiretroviral (ARV) drugs when used to treat disease or prevent mother-to-child transmission were not considered investigational.)
* Documented or suspected serious medical illness or immediate life-threatening condition (other than HIV infection) in the mother that may have interfered with the ability to complete study requirements, as judged by the examining cl
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
83
Allocation
Not provided
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Treatment
Key resources
Not provided
