Status:
COMPLETED
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to investigate the short-term antiviral potency of bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and participants who a...
Eligibility Criteria
Inclusion
- Key
- No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis \[PrEP\]), or postexposure prophylaxis (PEP) within 12 weeks of screening
- Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
- Cluster of differentiation 4+ (CD4+) cell count \> 200 cells/mm\^3
- Key
Exclusion
- Anticipated to start HIV-1 therapy during the study period
- Active participation in another study of investigational or approved ART agents
- A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
- Participants 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)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
October 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2015
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02275065
Start Date
October 24 2014
End Date
January 29 2015
Last Update
November 9 2020
Active Locations (16)
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1
Berkeley, California, United States
2
Davis, California, United States
3
Long Beach, California, United States
4
Los Angeles, California, United States