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Purpose

The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • HIV-1 RNA ≥ 500 copies/mL at screening. - Antiretroviral (ARV) treatment-naive, except the use of oral pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or F/TAF, up to 1 month prior to screening.

Exclusion Criteria

  • Prior use of any long acting parenteral antiretrovirals (ARVs) such as monoclonal antibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectable cabotegravir (including oral cabotegravir lead-in), and/or injectable rilpivirine. - Documented resistance to the integrase strand-transfer inhibitor class, specifically, resistance-associated mutations E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene. - Any of the following laboratory values at screening: 1. CD4 cell count < 200 cells/mm3 at screening. 2. Estimated glomerular filtrations arate < 60 mL/min according to the Modification of Diet in Renal Disease formula. 3. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) > 1.5 × upper limit of normal (ULN). 4. Direct bilirubin > 1.5 × ULN. 5. Platelets count < 50,000 cells/mm3. 6. Hemoglobin < 8.0 g/dL. - Active or occult hepatitis B virus infection. - Active hepatitis C virus infection. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Phase 2 of the study has 2 periods: Randomized and Extension, which are both open label. Phase 3 of the study has 2 periods: Randomized Period which would be double-blind (at least Week 96), followed by an Extension Period which will be Open-label.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2: GS-1720 + GS-4182 (Treatment Group 1) 		Participants will receive a 1-day loading dose of GS-1720 (1300 mg) and GS-4182 (600 mg) on Day 1.Thereafter, participants will take weekly doses of single agent GS-1720 (650 mg) and GS-4182 (300 mg) coadministered for at least 48 weeks.
  • Drug: GS-1720
    Tablets administered orally without regard to food
  • Drug: GS-4182
    Tablets administered orally without regard to food
Active Comparator
Phase 2: B/F/TAF (Treatment Group 2) 		Participants will receive B/F/TAF (50/200/25 mg) daily for at least 48 weeks.
  • Drug: Bictegravir/emtricitabine/tenofovir alafenamide
    Tablets administered orally without regard to food
    Other names:
    • Biktarvy ®
Experimental
Phase 2 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC) 		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 GS-1720/GS-4182 FDC (650/300 mg) weekly. Phase 2 Treatment Group 2 will receive a loading dose of GS-1720/GS-4182 FDC (1300 mg/600 mg) on Extension Phase Day 1, then GS-1720/GS-4182 FDC (650/300 mg) weekly. Participants who choose to enter the Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.
  • Drug: GS-1720/GS-4182 FDC
    Tablets administered orally without regard to food
Experimental
Phase 3: GS-1720/GS-4182 FDC + Placebo to Match (PTM) B/F/TAF (Treatment Group 1) 		Participants will receive a 1-day loading dose of GS-1720/GS-4182 FDC on Day 1. Thereafter, participants will receive GS-1720/GS-4182 FDC tablets weekly + PTM B/F/TAF once daily. Participants will receive treatment for at least 96 weeks.
  • Drug: GS-1720/GS-4182 FDC
    Tablets administered orally without regard to food
  • Drug: Placebo to Match BVY
    Tablets administered orally without regard to food
Active Comparator
Phase 3: B/F/TAF + PTM GS-1720/GS-4182 FDC (Treatment Group 2) 		Participants will receive oral B/F/TAF daily along with PTM GS-1720/GS-4182 FDC weekly for at least 96 weeks. Additionally, participants will receive a 1-day loading dose of PTM GS-1720/GS-4182 on Day 1.
  • Drug: Bictegravir/emtricitabine/tenofovir alafenamide
    Tablets administered orally without regard to food
    Other names:
    • Biktarvy ®
  • Drug: Placebo to Match GS1720/GS-4182 FDC
    Tablets administered orally without regard to food
Experimental
Phase 3 Extension Phase: GS-1720/GS-4182 Fixed-dose Combination (FDC) 		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 continue to receive GS-1720/GS-4182 FDC weekly while PTM B/F/TAF will be discontinued. Phase 3 Treatment Group 2 will switch to receive GS-1720/GS-4182 FDC tablets weekly. Participants in Treatment Group 2 will also receive a 1-day loading dose of GS-1720/GS-4182 FDC on Extension Phase Day 1. Participants who choose to enter the Phase 3 Extension Phase will receive GS-1720/GS-4182 FDC tablets until the product becomes available or until Gilead Sciences elects to discontinue the study, whichever occurs first.
  • Drug: GS-1720/GS-4182 FDC
    Tablets administered orally without regard to food

Recruiting Locations

UT Health San Antonio
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.