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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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