Summary

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

Description

Summary

The primary objective of this study is 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.

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 InfectionAntiviral AgentsGS-6207B/F/TAF

Eligibility

For people ages 18-65

Key Inclusion Criteria:

  • Plasma HIV-1 RNA ≥ 10,000 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 Centernot yet accepting patients
    TorranceCalifornia90502United States
  • Mills Clinical Researchaccepting new patients
    Los AngelesCalifornia90069United States
  • Ruane Clinical Research Group, Inc.accepting new patients
    Los AngelesCalifornia90036United States

Details

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