Isentress Re-examination Study (MK-0518-115)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice|
- Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment [ Time Frame: up to 14 days after last treatment ] [ Designated as safety issue: Yes ]
- Proportions of patients with HIV-1 RNA levels of less than 50 milliliter [ Time Frame: 6 months after treatment +/- 2 weeks ] [ Designated as safety issue: No ]
- Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter [ Time Frame: 6 months after treatment +/- 2 weeks ] [ Designated as safety issue: No ]
- Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible) [ Time Frame: 6 months after treatment +/- 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
HIV-1 Infected patients treated with Isentress
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042808
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|