Summary

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

Description

Summary

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

Keywords

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

Eligibility

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.

Locations

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03739866
Phase
Phase 1
Study Type
Interventional
Last Updated