A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA in treatment-naive HIV infected patients.
Phase 3
- Conditions
- Health Condition 1: B20- Human immunodeficiency virus [HIV]disease
- Registration Number
- CTRI/2009/091/000145
- Lead Sponsor
- Merck Sharp and Dohme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 750
Inclusion Criteria
Patient is male or female 18 years of age or older
Patient is HIV positive
Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART
Exclusion Criteria
Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
Patient has documented resistance to tenofovir or emtricitabine
Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
Patient is pregnant or breastfeeding, or expecting to conceive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HIV RNA <50 copies/ml, evaluation of safety and tolerabilityTimepoint: Time Frame: 48 weeks
- Secondary Outcome Measures
Name Time Method HIV RNA <50 copies/ml, evaluation of safety and tolerabilityTimepoint: Time Frame: 96 weeks