Stocrin Re-examination Study (0831-028)
Completed
- Conditions
- HIV Infection
- Registration Number
- NCT01065792
- 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 STOCRIN through collecting the safety and efficacy information 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
- 728
Inclusion Criteria
- HIV-1 Infected Patient
- Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.)
Exclusion Criteria
- Patient Who Has A Contraindication To Stocrin According To The Local Label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed) At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment Percent of patients with any adverse experience Up to 14 days following cessation of treatment
- Secondary Outcome Measures
Name Time Method