Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:2/8/2015
Start Date:October 2014
End Date:January 2015
Contact:Gilead Study Team
Email:GS9883studies@gilead.com

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A Phase 1b Randomized, Double-Blinded, Sequential Cohort Placebo-Controlled Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects

This study will investigate the short-term antiviral potency, safety, plasma
pharmacokinetics (PK), and the PK/pharmacodynamic (PD) relationship (the dose-response
relationship) of GS-9883 at multiple doses in antiretroviral (ART) treatment-naive adult
subjects and subjects who are ART-experienced but are currently off of ART therapy. Up to 32
participants will be enrolled in the study.


Inclusion Criteria:

- No current or prior anti-HIV treatment, including antiretroviral medications received
for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP)
within 12 weeks of screening

- Must be between 18 and 65 years of age, inclusive on the date of the screening visit

- Plasma HIV-1 RNA ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening

- CD4+ cell count > 200 cells/mm^3

Exclusion Criteria:

- Anticipated to start HIV-1 therapy during the study period

- Active participation in another study of investigational or approved antiretroviral
agents

- A new AIDS-defining condition diagnosed within the 30 days prior to screening

- Subjects with positive hepatitis C antibody at screening

- Chronic hepatitis B virus (HBV) infection

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)
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