Status:
TERMINATED
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1-infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the ...
Eligibility Criteria
Inclusion
- Key
- Plasma HIV-1 RNA ≥ 500 copies/mL at screening Visit
- Currently taking a failing ARV regimen that contains 2 NRTIs and a NNRTI
- No prior or current ARV regimens containing integrase inhibitor (INSTI) or protease inhibitor (PI)
- Screening genotype must show at least the protocol defined resistance mutation profile
- Key
Exclusion
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
- Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
- Use of an investigational drug other than the study drug
- Individuals with chronic hepatitis B virus (HBV) infection are not permitted to participate
- Active tuberculosis infection
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03472326
Start Date
April 3 2018
End Date
December 9 2019
Last Update
January 5 2021
Active Locations (2)
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1
Joint Clinical Research Centre
Kampala, Uganda, 10005
2
Joint Research Ethics Committee for the University of Zimbabwe College of Health Sciences and Parirenyatwa Group of Hospitals
Harare, Zimbabwe