CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 199 enrolled
Drug / intervention
GSK1265744 Tablets +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02178800
NCT02178800Phase 2Completed
CompareCT.gov

A Phase IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Investigational Injectable HIV Integrase Inhibitor, GSK1265744, in HIV-uninfected Men and Women

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 1, 2014·Updated Oct 18, 2021

In Brief

A Phase 2 clinical trial evaluating GSK1265744 Tablets, Injectable GSK1265744, and 2 other interventions for HIV Infections. Completed, enrolled 199 participants across 8 sites in 4 countries.

Detailed Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, Malawi, South Africa, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 1, 2014
Enrollment StartFeb 1, 2015
Primary CompletionApr 5, 2017
Study CompletionJul 13, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.0 years ago

Interventions

GSK1265744 Tabletsdrug

30-mg tablets, taken orally

Injectable GSK1265744drug

Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection

Placebo for GSK1265744 Tabletsdrug

Taken orally

Injectable Placebo for GSK1265744drug

Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection