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| Sponsor: | GlaxoSmithKline |
|---|---|
| Collaborator: |
Shionogi |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00920426 |
Purpose
The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood. It will also look at how people react to and how a human body uses GSK1265744. This study will compare the effects of GSK1265744 and placebo.
The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will take part in Part 1 of the study receiving dose A. If additional dosing information is needed after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.
| Condition | Intervention | Phase |
|---|---|---|
|
Acquired Immunodeficiency Syndrome |
Drug: GSK1265744 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2a Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK1265744 Monotherapy Versus Placebo in HIV-1 Infected Adults (ITZ112929) |
| Enrollment: | 9 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Cohort 1
Cohort 1 is the 5mg dose.
|
Drug: GSK1265744
Active drug
Drug: Placebo
Placebo to match GSK1265744
|
|
Cohort 2
Cohort 2 may be used to evaluate the next chosen dose.
|
Drug: GSK1265744
Active drug
Drug: Placebo
Placebo to match GSK1265744
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Note: One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Note: Study medications refer to GSK1265744 or placebo.
Exclusion Criteria for Screening ECG:
Males Females Heart rate <45 and >100 bpm <50 and >100 bpm QRS duration >120 msec >120 msec QTc interval (Bazett) > 450 msec > 450 msec Non-sustained (≥ 3 consecutive beats) or sustained ventricular tachycardia. Sinus Pauses >3 seconds. 2nd degree (Type II) or higher AV block. Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization)).
Contacts and Locations| United States, Florida | |
| GSK Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| GSK Investigational Site | |
| Vero Beach, Florida, United States, 32960 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Charlotte, North Carolina, United States, 28209 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00920426 History of Changes |
| Other Study ID Numbers: | 112929 |
| Study First Received: | June 12, 2009 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV naive Phase II integrase inhibitor GSK1265744 newly diagnosed |
pharmacokinetics AIDS integrase HIV Infections Treatment naive |
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |