A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects (ING114467)
- Conditions
- HIVHIV110047438
- Registration Number
- NL-OMON38393
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• HIV-1 infected subjects >=18 years of age.
• HIV-1 infection as documented by HIV-1 RNA >400 c/mL.
• No prior antiretroviral therapy.
• HLA-B*5701 negative.
• Safe contraception for women of childbearing potential.
• Breastfeeding, pregnancy.
• Any evidence of an active 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 the usual exceptions.
• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
• 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>E.g. the time to viral suppression (<50 copies/mL), the proportion of subjects<br /><br>with plasma HIV-1 RNA <50 copies/mL at Week 96 and 144, the change from<br /><br>baseline in CD4 at week 48, the proportion of subjects with HIV-1 RNA >=1,000<br /><br>copies/mL at or after 16 and before 24 weeks, or >= 200 copies/mL at 24 weeks,<br /><br>adverse events, quality of life.</p><br>