A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults.
- Conditions
- HIVHIV110047438
- Registration Number
- NL-OMON38097
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
* HIV-1 infected subjects *18 years of age.
* HIV-1 infection as documented by HIV-1 RNA >400 c/mL.
* Documented resistance to two or more different classes of antiretroviral agents.
* Integrase inhibitor-naïve.
* Safe contraception for women of childbearing potential.
* Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.
* Subject-virus is not evaluable using genotype/phenotype/tropism.
* Breastfeeding, pregnancy.
* Any evidence of an active Center for Disease and Prevention Control (CDC) Category C disease [CDC, 1993], except cutaneous Kaposi*s sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary.
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma.
* Treatment with any of the following agents within 28 days of Screening: radiation, cytotoxic chemotherapeutic agents, immunomodulators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>HIV1-RNA (<50 copies/ml) week 48.</p><br>
- Secondary Outcome Measures
Name Time Method <p>HIV1-RNA (<50 copies/ml) week 24, sign of resistance, virological and<br /><br>immunological response, disease progression, adverse events, PK parameters,<br /><br>quality of life.</p><br>