Study of GS-0415 and How It Works in People With HIV
ConditionHIV -1 Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGilead Sciences
About this trial
The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment.
The primary objectives of this study are to evaluate the safety and tolerability of escalating, single and multiple subcutaneous (SC) and intravenous (IV) doses of GS-0415, administered in PWH who are virologically suppressed on antiretroviral therapy (ART) and to evaluate the pharmacokinetics (PK) of GS-0415.
Eligibility criteria
Qualifiers
Age ≥ 18 years and age ≤ 65 years at screening
On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up
The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)
Plasma HIV-1 RNA < 50 copies/mL at screening with at least 2 documented HIV-1 RNA <50 copies/mL within the last 12 months.
Disqualifiers
Documented history of pre-ART CD4 nadir < 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable
Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable
Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration
Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
Trial design
Treatments tested in this trial
- GS-0415
- GS-0415 Placebo
Treatment groups
112 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov