NCT02178800 - Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults | Biotech Hunter

Enrollment

199

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

April 5, 2017

Study Completion Date

July 13, 2018

Conditions

HIV Infections

Interventions

DRUG

GSK1265744 Tablets

30-mg tablets, taken orally

DRUG

Injectable GSK1265744

"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"

DRUG

Placebo for GSK1265744 Tablets

Taken orally

DRUG

Injectable Placebo for GSK1265744

"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"

Trial Locations (8)

1862

Soweto HPTN CRS, Johannesburg

4013

Vulindlela CRS, Durban

20006

George Washington Univ. CRS, Washington D.C.

27599

Chapel Hill CRS, Chapel Hill

90035

UCLA CARE Center CRS, Los Angeles

94143

Bridge HIV CRS, San Francisco

21040-360

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

Unknown

Malawi CRS, Lilongwe

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH