Clinical trials
GS-US-643-7710
Identifier
NCT07645287
Link
https://clinicaltrials.gov/study/NCT07645287
Phase
Phase II
Status
Recruiting
Sponsor
Gilead Sciences
More details
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.
The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of swit
Purpose
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
Interventions
Intervention 1
GS-3242 Tablet
Intervention 2
GS-3242 Injection
Intervention 3
Lenacapavir Tablet
Intervention 4
Lenacapavir Injection
Intervention 5
B/F/TAF
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2026-06-15
Anticipated Date of Last Follow-up
2026-09-03
Estimated Primary Completion Date
2027-08-01
Estimated Completion Date
2033-04-01
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
No
Comments about the studied
populations
Key Inclusion Criteria:
* Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL for ≥ 6 months before screening.
* Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
* Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.
* No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S).
Key Exclusion Criteria:
* Prior use of, or exposure to GS-3242 or LEN.
* History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.
* Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadl
Health status
Positive to
: HIV
Other health status: Virologically Suppressed People With HIV
Study type
Interventional (clinical trial)
Enrollment
175
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other/Variable/Unknown
:
"unclear dosing frequency
"
Studied LA-formulation(s)
Injectable
Tablet
Studied route(s) of administration
Not provided
Use case
Treatment
Key resources
GS-US-643-6557
Identifier
NCT07708727
Link
https://clinicaltrials.gov/study/NCT07708727
Phase
Phase II/III
Status
Recruiting
Sponsor
Gilead Sciences
More details
The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.
The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.
The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.
The primary objectives of this study are:
Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B
Purpose
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
Interventions
Intervention 1
GS-3242 Tablet
Intervention 2
GS-3242 Injection
Intervention 3
Lenacapavir Tablet
Intervention 4
Lenacapavir Injection
Intervention 5
B/F/TAF
Countries
Not provided
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2026-07-01
Actual Start Date
2026-07-29
Anticipated Date of Last Follow-up
2026-09-04
Estimated Primary Completion Date
2030-10-01
Estimated Completion Date
2033-04-01
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
No
Comments about the studied
populations
Key Inclusion Criteria:
* HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening.
* Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening.
Key Exclusion Criteria:
* Prior usage of, or exposure to LEN or GS-3242
* Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
700
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Other/Variable/Unknown
:
"unclear dosing frequency
"
Studied LA-formulation(s)
Injectable
Tablet
Studied route(s) of administration
Oral
Intramuscular
Use case
Treatment
Key resources
Not provided
GS-US-544-5905-05
Identifier
NCT07001319
Link
https://clinicaltrials.gov/study/NCT07001319
Phase
Phase I
Status
Completed
Sponsor
Gilead Sciences
More details
This study is part of a master study. The goal of master protocol (GS-US-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH).
Substudy GS-US-544-5905-05 is to learn more about the study drug GS-3242 in PLHIV. Participants will receive single dose of GS-3242 450 mg on Days 1 and 2 in the fasted condition. On day 11, they intiate SoC or Biktarvy
Purpose
Study of GS-3242 in Participants With HIV-1; Substudy-05
Interventions
Intervention 1
GS-3242
Dosage: single oral dose 450mg on day1 and day2
Intervention 2
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
Intervention 3
Standard of Care examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
Countries
United States of America
Thailand
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2025-05-29
Anticipated Date of Last Follow-up
2026-05-08
Estimated Primary Completion Date
2026-04-01
Estimated Completion Date
2027-02-01
Actual Primary Completion Date
2026-03-03
Actual Completion Date
2026-04-16
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
All Substudies:
* Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening.
* Cluster of differentiation 4 (CD4) cell count \> 200 cells/mm\^3 at screening.
* Antiretroviral (ARV) treatment-naive or treatment-experienced but naive to the investigational ARV drug class being investigated in the given substudy and have not received any ARV within 12 weeks of screening, including medications received for pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) (note that current or prior receipt of long acting (LA) parenteral ARVs such as monoclonal antibodies (mAbs) targeting HIV-1, injectable cabotegravir (CAB), injectable rilpivirine (RPV) or injectable Lenacapavir (LEN) is exclusionary).
Health status
Positive to
: HIV
Negative to
: HCV, HBV
Study type
Interventional (clinical trial)
Enrollment
27
Allocation
Non-randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Tablet
Studied route(s) of administration
Oral
Use case
Treatment
Key resources
Not provided
