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Comparing new HIV treatments GS-1720 and GS-4182 with Biktarvy

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 Treatment-Naive People With HIV-1

Phase2; Phase3 Interventional Gilead Sciences · NCT06613685

This study is testing two new HIV treatments, GS-1720 and GS-4182, to see if they work better than the standard treatment Biktarvy for people who have never been treated before.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment675 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Locations52 sites (Birmingham, Alabama and 51 other locations)
Trial IDNCT06613685 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and efficacy of two experimental drugs, GS-1720 and GS-4182, in treating HIV-1 infection in treatment-naive individuals. The study consists of two phases: Phase 2 assesses the efficacy of the combination therapy at Week 24, while Phase 3 evaluates its effectiveness at Week 48 compared to the standard treatment Biktarvy. Participants will receive either the new drug combination or the standard treatment to determine which is more effective in managing HIV-1.

Who should consider this trial

Good fit: Ideal candidates are treatment-naive individuals with HIV-1 RNA levels of 500 copies/mL or higher.

Not a fit: Patients with prior use of long-acting antiretrovirals or documented resistance to integrase strand-transfer inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for individuals newly diagnosed with HIV-1.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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.

Key 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.

Where this trial is running

Birmingham, Alabama and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV-1-infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.