At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection confirmed
- ✓Age ≥18 years
- ✓On antiretroviral therapy for ≥12 consecutive months prior to baseline
- ✓Plasma HIV-1 RNA <50 copies/mL at screening and for ≥12 months preceding screening (at least 2 measurements)
- ✕Hepatitis B surface antigen (HBsAg) positive
- ✕Hepatitis C antibody (HCVAb) positive
- ✕Documented pre-ART CD4 nadir <200 cells/μL
- ✕New AIDS-defining condition within 90 days prior to screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Randomized, Blinded, Placebo-Controlled Dose-Escalation Study of the Safety and Biological Activity of GS-9620 in HIV-1 Infected, Virologically Suppressed Adults
In Brief
A Phase 1 clinical trial evaluating Vesatolimod, Placebo, and 1 other intervention for HIV-1 Infection. Completed, enrolled 48 participants across 8 sites.
Detailed Summary
The primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly GS-9620) in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.
Study Details
Timeline
Interventions
Tablet(s) administered orally once every 2 weeks
Tablet(s) administered orally once every 2 weeks
Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.