for people ages 18-65 (full criteria)
study started
estimated completion



This study has 2 parts: Part A (Cohorts 1-5) and Part B (Cohorts 6-8). The primary objectives of this study are: Part A: To evaluate the short-term antiviral activity of GS-6207 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are experienced but capsid inhibitor (CAI) naive. Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced but without resistance to TAF.

Official Title

A Phase 1b Randomized, Double-Blinded, Placebo Controlled, Multi-Cohort Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Subjects


HIV-1 Infection Antiviral Agents B/F/TAF TAF


For people ages 18-65

Key Inclusion Criteria:

  • Plasma HIV-1 RNA ≥ 5,000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count > 200 cells/mm3

  • Treatment naive or experienced but CAI and integrase strand transfer inhibitor (INSTI) naïve, and have not received any antiretroviral therapy (ART) within 12 weeks of screening
  • Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on Day 10
  • Screening genotype report must show sensitivity to at least one agent in either non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) class to allow its use as part of standard of care oral antiretroviral treatment in the future
  • Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)
  • No clinically significant abnormalities in ECG at Screening
  • Willing to initiate B/F/TAF on Day 10 after completion of all assessments

Key Exclusion Criteria:

  • Pregnant or lactating

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center not yet accepting patients
    Torrance California 90502 United States
  • Mills Clinical Research accepting new patients
    Los Angeles California 90069 United States
  • Ruane Clinical Research Group, Inc. accepting new patients
    Los Angeles California 90036 United States


accepting new patients
Start Date
Completion Date
Gilead Sciences
Phase 1
Study Type
Last Updated