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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Hiv
  • Age: Between 18 Year(s) - 110 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
    2. Receiving Biktarvy for ≥ 24 weeks prior to screening.

You may not be eligible for this study if the following are true:

    1. Prior use of, or exposure to LEN, GS-1720, or GS-4182.
    2. History of virologic failure while on an INSTI-based regimen
    3. Prior use of any LA parenteral ARVs such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
    4. Active tuberculosis infection.
    5. Active or occult hepatitis B virus (HBV) infection.
    6. Active hepatitis C virus (HCV).
    7. Decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
    8. Have been treated within 6 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic [at least 4 weeks] systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies).
    9. Positive serum pregnancy test at screening or positive pregnancy test at Day 1
    10. Participants with plans to breastfeed during the study period and within 60 days following the last dose of study drug.
    11. Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period or active malignancy requiring acute systemic treatment.



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