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:
- 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.
- Receiving Biktarvy for ≥ 24 weeks prior to screening.
You may not be eligible for this study if the following are true:
-
- Prior use of, or exposure to LEN, GS-1720, or GS-4182.
- History of virologic failure while on an INSTI-based regimen
- 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.
- Active tuberculosis infection.
- Active or occult hepatitis B virus (HBV) infection.
- Active hepatitis C virus (HCV).
- Decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- 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).
- Positive serum pregnancy test at screening or positive pregnancy test at Day 1
- Participants with plans to breastfeed during the study period and within 60 days following the last dose of study drug.
- Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period or active malignancy requiring acute systemic treatment.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.