HIV-1-infectionPhase 2/3NCT07708727
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
A Phase 2/3 study testing GS-3242 Tablet, GS-3242 Injection and Lenacapavir Tablet in people with HIV-1-infection, run by Gilead Sciences at 16 sites in 3 countries.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- GS-3242 Tablet, GS-3242 Injection and Lenacapavir Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 29 Jul 2026to Apr 2033
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
16 sites in 3 countries
United States12 sites, 12 recruiting
- Recruiting
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
- Recruiting
St Hope Foundation, Inc,
Bellaire, Texas, 77401
- Recruiting
Prism Health North Texas
Dallas, Texas, 75208
- Recruiting
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, 75246
- Recruiting
Metro Infectious Disease Consultants, P.L.L.C
Decatur, Georgia, 30033
- Recruiting
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76109
- Recruiting
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
- Recruiting
KC care Health Center
Kansas City, Missouri, 64111
- Recruiting
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, 06510
- Recruiting
Orlando Immunology Center, PA
Orlando, Florida, 32803
- Recruiting
Lundquist Inst Biomedical Innovation Harbor-UCLA
Torrance, California, 90502
- Recruiting
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33401
Canada2 sites, 2 recruiting
- Recruiting
McGill University Health Centre
Decarie Montreal, H4A 3J1
- Recruiting
CHU de Québec-Université Laval
Québec, G1V 4G2
Puerto Rico2 sites, 2 recruiting
- Recruiting
Proyecto ACTU
Rio Piedras, PR, 00925
- Recruiting
HOPE Clinical Research
San Juan, PR, 00909
About this study
Official title: An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1
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.
Read more
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/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.
- Conditions
- HIV-1-infection
- Being tested
- GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection, B/F/TAF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-3242 TabletDrug
Administered orally
GS-3242 InjectionDrug
Administered intramuscularly (IM)
Lenacapavir TabletDrug
Also called LEN
Administered orally
Lenacapavir InjectionDrug
Also called LEN
Administered IM
B/F/TAFDrug
Also called Biktarvy
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: Part A: Group 1 of GS-3242 + LEN | Experimental | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN for at least 52 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Phase 2: Part A: Group 2 of GS-3242 + LEN | Experimental | Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Phase 2: Part A: Group 3 of B/F/TAF | Experimental | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks. Receives: Drug: B/F/TAF |
| Phase 2: Part B: Group 4 of GS-3242 + LEN | Experimental | Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Phase 3: Group 1 of GS-3242 + LEN | Experimental | Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks. Receives: Drug: GS-3242 Tablet; Drug: GS-3242 Injection; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Phase 3: Group 2 of B/F/TAF | Experimental | Participants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks. Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Measured: Week 35
Phase 2: Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Measured: Week 26
Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Measured: Week 52
Secondary outcomes (19)
Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm
Measured: Week 12
Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Measured: Week 52
Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Measured: Baseline, Week 12
Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35
Measured: Baseline, Week 35
Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52
Measured: Baseline, Week 52
Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26
Measured: Baseline, Week 26
Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12
Measured: From first dose date up to Week 12
Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35
Measured: Week 35
Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Measured: From first dose date up to Week 26
Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Measured: From first dose date up to Week 52
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18
Measured: Week 18
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35
Measured: Week 35
Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52
Measured: Week 52
Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26
Measured: Week 26
Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm
Measured: Week 104
Phase 3: Change From Baseline in CD4 Cell Count at Week 52
Measured: Baseline, Week 52
Phase 3: Change From Baseline in CD4 Cell Count at Week 104
Measured: Baseline, Week 104
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Measured: From first dose up to Week 52
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104
Measured: From first dose up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start29 Jul 2026
- Primary completionOct 2030 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708727
- Sponsor's protocol ID
- GS-US-643-6557
- Other IDs
- 2026-526026-40
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1
- ClinicalTrials.gov ID
- NCT07708727
- Acronym / sponsor ID
- GS-US-643-6557
- Conditions
- HIV-1-infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 2: Part A: Group 1 of GS-3242 + LEN | Experimental | Drug: GS-3242 Tablet, Drug: GS-3242 Injection, Drug: Lenacapavir Tablet, Drug: Lenacapavir InjectionParticipants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN for at least 52 weeks. |
| Phase 2: Part A: Group 2 of GS-3242 + LEN | Experimental | Drug: GS-3242 Tablet, Drug: GS-3242 Injection, Drug: Lenacapavir Tablet, Drug: Lenacapavir InjectionParticipants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks. |
| Phase 2: Part A: Group 3 of B/F/TAF | Experimental | Drug: B/F/TAFParticipants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 52 weeks. |
| Phase 2: Part B: Group 4 of GS-3242 + LEN | Experimental | Drug: GS-3242 Tablet, Drug: GS-3242 Injection, Drug: Lenacapavir Tablet, Drug: Lenacapavir InjectionParticipants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks. |
| Phase 3: Group 1 of GS-3242 + LEN | Experimental | Drug: GS-3242 Tablet, Drug: GS-3242 Injection, Drug: Lenacapavir Tablet, Drug: Lenacapavir InjectionParticipants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks. |
| Phase 3: Group 2 of B/F/TAF | Experimental | Drug: B/F/TAFParticipants will be randomized to receive 50/200/25 mg of B/F/TAF daily for at least 104 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-3242 TabletAdministered orally | Drug | Phase 2: Part A: Group 1 of GS-3242 + LEN, Phase 2: Part A: Group 2 of GS-3242 + LEN, Phase 2: Part B: Group 4 of GS-3242 + LEN, Phase 3: Group 1 of GS-3242 + LEN |
| GS-3242 InjectionAdministered intramuscularly (IM) | Drug | Phase 2: Part A: Group 1 of GS-3242 + LEN, Phase 2: Part A: Group 2 of GS-3242 + LEN, Phase 2: Part B: Group 4 of GS-3242 + LEN, Phase 3: Group 1 of GS-3242 + LEN |
| Lenacapavir TabletAlso: LENAdministered orally | Drug | Phase 2: Part A: Group 1 of GS-3242 + LEN, Phase 2: Part A: Group 2 of GS-3242 + LEN, Phase 2: Part B: Group 4 of GS-3242 + LEN, Phase 3: Group 1 of GS-3242 + LEN |
| Lenacapavir InjectionAlso: LENAdministered IM | Drug | Phase 2: Part A: Group 1 of GS-3242 + LEN, Phase 2: Part A: Group 2 of GS-3242 + LEN, Phase 2: Part B: Group 4 of GS-3242 + LEN, Phase 3: Group 1 of GS-3242 + LEN |
| B/F/TAFAlso: BiktarvyAdministered orally | Drug | Phase 2: Part A: Group 3 of B/F/TAF, Phase 3: Group 2 of B/F/TAF |
Primary outcome
Phase 2: Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Time frame: Week 35
Phase 2: Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 26
Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 52
19 secondary outcomes
Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 12
Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm
Time frame: Week 52
Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Time frame: Baseline, Week 12
Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35
Time frame: Baseline, Week 35
Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52
Time frame: Baseline, Week 52
Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26
Time frame: Baseline, Week 26
Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12
Time frame: From first dose date up to Week 12
Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35
Time frame: Week 35
Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Time frame: From first dose date up to Week 26
Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Time frame: From first dose date up to Week 52
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18
Time frame: Week 18
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35
Time frame: Week 35
Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52
Time frame: Week 52
Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26
Time frame: Week 26
Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm
Time frame: Week 104
Phase 3: Change From Baseline in CD4 Cell Count at Week 52
Time frame: Baseline, Week 52
Phase 3: Change From Baseline in CD4 Cell Count at Week 104
Time frame: Baseline, Week 104
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Time frame: From first dose up to Week 52
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104
Time frame: From first dose up to Week 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GS-3242 Tablet, GS-3242 Injection and Lenacapavir Tablet in people with HIV-1-infection, run by Gilead Sciences at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), leadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm (time frame: Week 35). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.