At a glance
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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
In Brief
A Phase 1 clinical trial evaluating Lenacapavir, Placebo, and 2 other interventions for HIV-1 Infection. Completed, enrolled 53 participants across 12 sites.
Detailed Summary
The primary objectives of this study are: Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 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.
Study Details
Timeline
Interventions
Administered subcutaneously in the abdomen
Administered subcutaneously in the abdomen
50/200/25 mg tablets administered orally once daily
Tablets administered orally