drugset / Trial / NCT02275065

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants

NCT02275065 ↗

Phase 1 Completed 23 enrolled Gilead Sciences
RandomizedSequentialQuadruple-blindTreatment

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 are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.

Timeline

Start
2014-10-24
Primary completion
2015-01-23
Completion
2015-01-29

Outcome

Met primary endpoint

registry analysis (other test); Bictegravir 100 mg vs Placebo; p <0.001; t-test, 2 sided NCT02275065 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bictegravir Small molecule 5 mg Oral
Subject Bictegravir Small molecule 25 mg Oral
Subject Bictegravir Small molecule 50 mg Oral
Subject Bictegravir Small molecule 100 mg Oral