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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00708110 |
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.
Condition | Intervention | Phase |
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HIV-1 Infection |
Drug: GSK1349572 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | 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) |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
GSK Investigational Site | |
San Francisco, California, United States, 94115 | |
GSK Investigational Site | |
Newport Beach, California, United States, 92663 | |
GSK Investigational Site | |
Bakersfield, California, United States, 93301 | |
GSK Investigational Site | |
Long Beach, California, United States, 90813 | |
United States, Colorado | |
GSK Investigational Site | |
Denver, Colorado, United States, 80220 | |
United States, District of Columbia | |
GSK Investigational Site | |
Washington, District of Columbia, United States, 20009 | |
United States, Florida | |
GSK Investigational Site | |
Orlando, Florida, United States, 32803 | |
GSK Investigational Site | |
Vero Beach, Florida, United States, 32960 | |
GSK Investigational Site | |
Fort Lauderdale, Florida, United States, 33316 | |
GSK Investigational Site | |
Ft. Lauderdale, Florida, United States, 33306 | |
United States, Georgia | |
GSK Investigational Site | |
Atlanta, Georgia, United States, 30308 | |
United States, New Jersey | |
GSK Investigational Site | |
Voorhees, New Jersey, United States, 08043 | |
GSK Investigational Site | |
Hillsborough, New Jersey, United States, 08844 | |
United States, New Mexico | |
GSK Investigational Site | |
Santa Fe, New Mexico, United States, 87505 | |
United States, North Carolina | |
GSK Investigational Site | |
Charlotte, North Carolina, United States, 28209 | |
United States, Texas | |
GSK Investigational Site | |
Dallas, Texas, United States, 75204 | |
GSK Investigational Site | |
Dallas, Texas, United States, 75246 |
Study Director: | GSK Clinical Trials, MD, MPH | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111521 |
Study First Received: | June 30, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00708110 |
Health Authority: | United States: Food and Drug Administration |
HIV-1 infection integrase inhibitor dose-ranging study phase IIa |
HIV Infections Acquired Immunodeficiency Syndrome |
Infection |