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 |
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.
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)
We found this trial at
16
sites
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