NCT00708110

Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults

A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK1349572 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults (ING111521)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect, safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10 days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral therapy. This study consists of a screening visit, a treatment period and a follow-up evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK1349572	GSK1349572 is an experimental drug being developed for the treatment of HIV. It is in the class of integrase inhibitors.
DRUG	Placebo	Placebo is a tablet with no drug in it.

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-07-02
• Last updated: 2013-12-05
• Results posted: 2013-10-30

Locations

18 sites across 1 country: United States