Stocrin Re-examination Study (0831-028)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice|
- Percent of patients with any adverse experience [ Time Frame: Up to 14 days following cessation of treatment ] [ Designated as safety issue: Yes ]
- Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment [ Time Frame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment ] [ Designated as safety issue: No ]
- Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed) [ Time Frame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Patients with HIV-1 infection taking Stocrin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065792
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|