Isentress Re-examination Study (MK-0518-115)
Completed
- Conditions
- HIV InfectionHIV Infections
- Registration Number
- NCT01042808
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Isentress through collecting the safety and efficacy information in usual practice according to the Re-examination Regulation for New Drugs.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 996
Inclusion Criteria
- HIV-1 Infected Adults
- Treated with Isentress 400 mg tablet within local label during the enrollment period
Exclusion Criteria
- Contraindication to Isentress according to the local label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment up to 14 days after last treatment Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible) 6 months after treatment +/- 2 weeks Proportions of patients with HIV-1 RNA levels of less than 50 milliliter 6 months after treatment +/- 2 weeks Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter 6 months after treatment +/- 2 weeks
- Secondary Outcome Measures
Name Time Method