HIV-1-InfectionPhase 2/3WONDERS1NCT06544733
Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
A Phase 2/3 study testing Lepetegravir, Lenacapavir pacfosacil and Bictegravir/emtricitabine/tenofovir alafenamide in people with HIV-1-Infection, run by Gilead Sciences at 39 sites in 2 countries.
Trial summary
The goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the… 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?
- Lepetegravir, Lenacapavir pacfosacil and Bictegravir/emtricitabine/tenofovir alafenamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 675 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 20 Aug 2024to Jun 2029
- 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
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
- Receiving BVY for ≥ 24 weeks prior to screening.
Who cannot join
- Prior use of, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil.
- History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
- Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
- Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
- Any of the following laboratory values at screening:
- Clusters of differentiation 4 (CD4) cell count < 200 cells/mm^3 at screening
Show all 14Show fewer
- Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula
- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN)
- Direct bilirubin > 1.5 × ULN
- Platelets count < 50,000 cells/mm^3
- Hemoglobin < 8.0 g/dL
- Active or occult hepatitis B virus (HBV) infection.
- Active hepatitis C virus (HCV).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States35 sites
Central Texas Clinical Research
Austin, Texas, 78705
St Hope Foundation, Inc.
Bellaire, Texas, 77401
Be Well Medical Center
Berkley, Michigan, 48072
Pacific Oaks Medical Group
Beverly Hills, California, 90211
UAB 1917 Research Clinic
Birmingham, Alabama, 35294
Prism Health North Texas, Oak Cliff Health Center
Dallas, Texas, 75215
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, 75246
Metro Infectious Disease Consultants, P.L.L.C.
Decatur, Georgia, 30033
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
AXCES Research Group, LLC
El Paso, Texas, 79902
NewYork-Presbyterian Queens
Flushing, New York, 11355
CAN Community Health
Fort Lauderdale, Florida, 33316
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76104
Midway and Immunology Research Center
Ft. Pierce, Florida, 34982
The Crofoot Research Center, INC.
Houston, Texas, 77098
Rosedale Health and Wellness
Huntersville, North Carolina, 28078
KC CARE Health Center
Kansas City, Missouri, 64111
DCOL Center for Clinical Research
Longview, Texas, 75605
Ruane Clinical Research Group
Los Angeles, California, 90036
Mills Clinical Research
Los Angeles, California, 90069
Mercer University, Department of Internal Medicine
Macon, Georgia, 31201
AIDS Healthcare Foundation - The Kinder Medical Group
Miami, Florida, 33133
Floridian Clinical Research
Miami Lakes, Florida, 33016
NYU Langone Health Vaccine Center
New York, New York, 10016
Saint Michael's Medical Center
Newark, New Jersey, 07102
Orlando Immunology Center
Orlando, Florida, 32803
BIOS Clinical Research
Palm Springs, California, 92262
UCSF Division of HIV, Infectious Diseases & Global Medicine
San Francisco, California, 94110
AXCES Research Group, LLC
Santa Fe, New Mexico, 87505
CAN Community Health
Sarasota, Florida, 34237
Chatham County Health Department
Savannah, Georgia, 31401
Peter Shalit, MD
Seattle, Washington, 98104
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33407
Puerto Rico4 sites
Centro Ararat, Inc.
San Juan, PR, 00717
Clinical Research Puerto Rico
San Juan, PR, 00909-1711
HOPE Clinical Research
San Juan, PR, 00909
Proyecto ACTC
San Juan, PR, 00935
About this study
Official title: An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1
The goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of lepetegravir and lenacapavir pacfosacil is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection.
This study has two phases: Phase 2 and Phase 3.
Read more
The primary objectives of this study are:
Phase 2: To evaluate the efficacy of switching to oral weekly lepetegravir in combination with lenacapavir pacfosacil versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24.
Phase 3: To evaluate the efficacy of switching to oral weekly lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.
- Conditions
- HIV-1-Infection
- Being tested
- Lepetegravir, Lenacapavir pacfosacil, Placebo to Match BVY, Bictegravir/emtricitabine/tenofovir alafenamide, Lepetegravir/Lenacapavir pacfosacil FDC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LepetegravirDrug
Also called GS-1720
Tablets administered orally without regard to food
Lenacapavir pacfosacilDrug
Also called GS-4182
Tablets administered orally without regard to food
Placebo to Match BVYDrug
Tablets administered orally without regard to food
Bictegravir/emtricitabine/tenofovir alafenamideDrug
Also called Biktarvy®
Tablets administered orally without regard to food
Lepetegravir/Lenacapavir pacfosacil FDCDrug
Also called GS-1720/GS-4182 FDC
Tablets administered orally without regard to food
Placebo to Match GS1720/GS-4182 FDCDrug
Tablets administered orally without regard to food
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: Lepetegravir + Lenacapavir pacfosacil (Treatment Group 1) | Experimental | Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will switch to lepetegravir (650 mg tablet) and lenacapavir pacfosacil (300 mg tablet) coadministered. Participants will receive a 1-day loading dose of lepetegravir (1300 mg) and lenacapavir pacfosacil (600 mg) on Day 1. Thereafter, participants will take weekly doses of single agent lepetegravir (650 mg) and lenacapavir pacfosacil (300 mg) coadministered for at least 48 weeks. Receives: Drug: Lepetegravir; Drug: Lenacapavir pacfosacil |
| Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2) | Active comparator | Participants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will continue receiving BVY daily for at least 48 weeks. Receives: Drug: Bictegravir/emtricitabine/tenofovir alafenamide |
| Phase 2 Extension Phase: Lepetegravir /Lenacapavir pacfosacil Fixed-dose Combination (FDC) | Experimental | At the end of the randomized treatment, Phase 2 participants will be given the option to participate in the Extension Phase. Phase 2 Treatment Group 1 will switch to lepetegravir /lenacapavir pacfosacil FDC weekly. Phase 2 Treatment Group 2 will receive a loading dose of lepetegravir /lenacapavir pacfosacil FDC on Extension Phase Day 1 then, lepetegravir/lenacapavir pacfosacil FDC weekly. Participants who choose to enter the Extension Phase will receive lepetegravir /lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. Receives: Drug: Lepetegravir/Lenacapavir pacfosacil FDC |
| Phase 3: Lepetegravir /Lenacapavir pacfosacil FDC + Placebo to Match (PTM) BVY (Treatment Group 1) | Experimental | Participants who have been virologically suppressed on BVY will switch from BVY to lepetegravir/lenacapavir pacfosacil FDC tablets weekly + placebo-to-match (PTM) BVY once daily. In addition, participants will receive a 1-day loading dose regimen of lepetegravir /lenacapavir pacfosacil FDC on Day 1.
Participants will receive treatment for at least 96 weeks. Receives: Drug: Placebo to Match BVY; Drug: Lepetegravir/Lenacapavir pacfosacil FDC |
| Phase 3: BVY Placebo to Match Lepetegravir /Lenacapavir pacfosacil FDC + BVY (Treatment Group 2) | Active comparator | Participants who have been virologically suppressed on BVY will continue receiving oral BVY daily. In addition, participants will receive a 1-day loading dose of PTM lepetegravir /lenacapavir pacfosacil on Day 1 and weekly PTM thereafter. Participants will receive treatment for at least 96 weeks. Receives: Drug: Bictegravir/emtricitabine/tenofovir alafenamide; Drug: Placebo to Match GS1720/GS-4182 FDC |
| Phase 3 Extension Phase: Lepetegravir/Lenacapavir pacfosacil Fixed-dose Combination (FDC) | Experimental | After the end of blinded treatment, Phase 3 participants will be given the option to participate in the Extension Phase. Phase 3 Treatment Group 1 will switch to lepetegravir/lenacapavir pacfosacil FDC weekly. Phase 3 Treatment Group 2 will receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Extension Phase Day 1, then lepetegravir/lenacapavir pacfosacil FDC weekly. Participants who choose to enter the Extension Phase will receive lepetegravir/lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. Receives: Drug: Lepetegravir/Lenacapavir pacfosacil FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-defined Snapshot Algorithm
Measured: Week 24
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 48
Secondary outcomes (27)
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 12
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 48
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 12
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 24
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 48
Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4+) T-cell Count at Week 12
Measured: Baseline, Week 12
Phase 2: Change From Baseline in CD4+ T-cell Count at Week 24
Measured: Baseline, Week 24
Phase 2: Change From Baseline in CD4+ T-cell Count at Week 48
Measured: Baseline, Week 48
Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Through Week 12
Measured: First dose date up to Week 12
Phase 2: Percentage of Participants Experiencing TEAEs Through Week 24
Measured: First dose date up to Week 24
Phase 2: Percentage of Participants Experiencing TEAEs Through Week 48
Measured: First dose date up to Week 48
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 12
Measured: First dose date up to Week 12
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 24
Measured: First dose date up to Week 24
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48
Measured: First dose date up to Week 48
Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Lepetegravir and Lenacapavir (LEN)
Cmax is defined as the maximum observed concentration of drug.
Measured: Day 1 up to Week 48
Phase 2: PK Parameter: Tmax of Lepetegravir and LEN
Tmax is defined as the time (observed time point) of Cmax.
Measured: Day 1 up to Week 48
Phase 2: PK Parameter: Ctau of Lepetegravir and LEN
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: Day 1 up to Week 48
Phase 2: PK Parameter: AUCtau of Lepetegravir and LEN
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: Day 1 up to Week 48
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 96
Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 48
Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
Measured: Week 96
Phase 3: Change From Baseline in CD4+ T-cell Count at Week 48
Measured: Baseline, Week 48
Phase 3: Change From Baseline in CD4+ T-cell Count at Week 96
Measured: Baseline, Week 96
Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48
Measured: First dose date up to Week 48
Phase 3: Proportion of Participants Experiencing TEAEs Through Week 96
Measured: First dose date up to Week 96
Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48
Measured: First dose date up to Week 48
Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 96
Measured: First dose date up to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start20 Aug 2024
- Primary completionJan 2028 (estimated)
- Study completionJun 2029 (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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 675 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
- NCT06544733
- Sponsor's protocol ID
- GS-US-695-6509
- Other IDs
- 2024-511054-50
- Acronym
- WONDERS1
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2024
- Last updated
- 17 Apr 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1
- ClinicalTrials.gov ID
- NCT06544733
- Acronym / sponsor ID
- WONDERS1 / GS-US-695-6509
- Conditions
- HIV-1-Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 9 Aug 2024 (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 goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of lepetegravir and lenacapavir pacfosacil is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection.
This study has two phases: Phase 2 and Phase 3.
The primary objectives of this study are:
Phase 2: To evaluate the efficacy of switching to oral weekly lepetegravir in combination with lenacapavir pacfosacil versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24.
Phase 3: To evaluate the efficacy of switching to oral weekly lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 2: Lepetegravir + Lenacapavir pacfosacil (Treatment Group 1) | Experimental | Drug: Lepetegravir, Drug: Lenacapavir pacfosacilParticipants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will switch to lepetegravir (650 mg tablet) and lenacapavir pacfosacil (300 mg tablet) coadministered. Participants will receive a 1-day loading dose of lepetegravir (1300 mg) and lenacapavir pacfosacil (600 mg) on Day 1. Thereafter, participants will take weekly doses of single agent lepetegravir (650 mg) and lenacapavir pacfosacil (300 mg) coadministered for at least 48 weeks. |
| Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2) | Active comparator | Drug: Bictegravir/emtricitabine/tenofovir alafenamideParticipants who have been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BVY) will continue receiving BVY daily for at least 48 weeks. |
| Phase 2 Extension Phase: Lepetegravir /Lenacapavir pacfosacil Fixed-dose Combination (FDC) | Experimental | Drug: Lepetegravir/Lenacapavir pacfosacil FDCAt the end of the randomized treatment, Phase 2 participants will be given the option to participate in the Extension Phase. Phase 2 Treatment Group 1 will switch to lepetegravir /lenacapavir pacfosacil FDC weekly. Phase 2 Treatment Group 2 will receive a loading dose of lepetegravir /lenacapavir pacfosacil FDC on Extension Phase Day 1 then, lepetegravir/lenacapavir pacfosacil FDC weekly. Participants who choose to enter the Extension Phase will receive lepetegravir /lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. |
| Phase 3: Lepetegravir /Lenacapavir pacfosacil FDC + Placebo to Match (PTM) BVY (Treatment Group 1) | Experimental | Drug: Placebo to Match BVY, Drug: Lepetegravir/Lenacapavir pacfosacil FDCParticipants who have been virologically suppressed on BVY will switch from BVY to lepetegravir/lenacapavir pacfosacil FDC tablets weekly + placebo-to-match (PTM) BVY once daily. In addition, participants will receive a 1-day loading dose regimen of lepetegravir /lenacapavir pacfosacil FDC on Day 1. Participants will receive treatment for at least 96 weeks. |
| Phase 3: BVY Placebo to Match Lepetegravir /Lenacapavir pacfosacil FDC + BVY (Treatment Group 2) | Active comparator | Drug: Bictegravir/emtricitabine/tenofovir alafenamide, Drug: Placebo to Match GS1720/GS-4182 FDCParticipants who have been virologically suppressed on BVY will continue receiving oral BVY daily. In addition, participants will receive a 1-day loading dose of PTM lepetegravir /lenacapavir pacfosacil on Day 1 and weekly PTM thereafter. Participants will receive treatment for at least 96 weeks. |
| Phase 3 Extension Phase: Lepetegravir/Lenacapavir pacfosacil Fixed-dose Combination (FDC) | Experimental | Drug: Lepetegravir/Lenacapavir pacfosacil FDCAfter the end of blinded treatment, Phase 3 participants will be given the option to participate in the Extension Phase. Phase 3 Treatment Group 1 will switch to lepetegravir/lenacapavir pacfosacil FDC weekly. Phase 3 Treatment Group 2 will receive a 1-day loading dose of lepetegravir/lenacapavir pacfosacil FDC on Extension Phase Day 1, then lepetegravir/lenacapavir pacfosacil FDC weekly. Participants who choose to enter the Extension Phase will receive lepetegravir/lenacapavir pacfosacil FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
- Receiving BVY for ≥ 24 weeks prior to screening.
Key exclusion criteria (14 listed)
- Prior use of, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil.
- History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
- Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
- Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
- Any of the following laboratory values at screening:
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 |
|---|---|---|
| LepetegravirAlso: GS-1720Tablets administered orally without regard to food | Drug | Phase 2: Lepetegravir + Lenacapavir pacfosacil (Treatment Group 1) |
| Lenacapavir pacfosacilAlso: GS-4182Tablets administered orally without regard to food | Drug | Phase 2: Lepetegravir + Lenacapavir pacfosacil (Treatment Group 1) |
| Placebo to Match BVYTablets administered orally without regard to food | Drug | Phase 3: Lepetegravir /Lenacapavir pacfosacil FDC + Placebo to Match (PTM) BVY (Treatment Group 1) |
| Bictegravir/emtricitabine/tenofovir alafenamideAlso: Biktarvy®Tablets administered orally without regard to food | Drug | Phase 2: Bictegravir/emtricitabine/tenofovir alafenamide (BVY) (Treatment Group 2), Phase 3: BVY Placebo to Match Lepetegravir /Lenacapavir pacfosacil FDC + BVY (Treatment Group 2) |
| Lepetegravir/Lenacapavir pacfosacil FDCAlso: GS-1720/GS-4182 FDCTablets administered orally without regard to food | Drug | Phase 2 Extension Phase: Lepetegravir /Lenacapavir pacfosacil Fixed-dose Combination (FDC), Phase 3 Extension Phase: Lepetegravir/Lenacapavir pacfosacil Fixed-dose Combination (FDC), Phase 3: Lepetegravir /Lenacapavir pacfosacil FDC + Placebo to Match (PTM) BVY (Treatment Group 1) |
| Placebo to Match GS1720/GS-4182 FDCTablets administered orally without regard to food | Drug | Phase 3: BVY Placebo to Match Lepetegravir /Lenacapavir pacfosacil FDC + BVY (Treatment Group 2) |
Primary outcome
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-defined Snapshot Algorithm
Time frame: Week 24
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
27 secondary outcomes
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 12
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 12
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 24
Phase 2: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Phase 2: Change From Baseline in Clusters of Differentiation 4 (CD4+) T-cell Count at Week 12
Time frame: Baseline, Week 12
Phase 2: Change From Baseline in CD4+ T-cell Count at Week 24
Time frame: Baseline, Week 24
Phase 2: Change From Baseline in CD4+ T-cell Count at Week 48
Time frame: Baseline, Week 48
Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Through Week 12
Time frame: First dose date up to Week 12
Phase 2: Percentage of Participants Experiencing TEAEs Through Week 24
Time frame: First dose date up to Week 24
Phase 2: Percentage of Participants Experiencing TEAEs Through Week 48
Time frame: First dose date up to Week 48
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 12
Time frame: First dose date up to Week 12
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 24
Time frame: First dose date up to Week 24
Phase 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48
Time frame: First dose date up to Week 48
Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Lepetegravir and Lenacapavir (LEN)
Time frame: Day 1 up to Week 48
Phase 2: PK Parameter: Tmax of Lepetegravir and LEN
Time frame: Day 1 up to Week 48
Phase 2: PK Parameter: Ctau of Lepetegravir and LEN
Time frame: Day 1 up to Week 48
Phase 2: PK Parameter: AUCtau of Lepetegravir and LEN
Time frame: Day 1 up to Week 48
Phase 3: Proportion of Participants With HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 96
Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Phase 3: Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 96
Phase 3: Change From Baseline in CD4+ T-cell Count at Week 48
Time frame: Baseline, Week 48
Phase 3: Change From Baseline in CD4+ T-cell Count at Week 96
Time frame: Baseline, Week 96
Phase 3: Percentage of Participants Experiencing TEAEs Through Week 48
Time frame: First dose date up to Week 48
Phase 3: Proportion of Participants Experiencing TEAEs Through Week 96
Time frame: First dose date up to Week 96
Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 48
Time frame: First dose date up to Week 48
Phase 3: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 96
Time frame: First dose date up to Week 96
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 17 Apr 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. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lepetegravir, Lenacapavir pacfosacil and Bictegravir/emtricitabine/tenofovir alafenamide in people with HIV-1-Infection, run by Gilead Sciences at 39 sites in 2 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 14 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-defined Snapshot Algorithm (time frame: Week 24). The study lists 2 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 17 Apr 2026.