Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

Open to people ages 18 years and up

• 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.

• 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.