Isentress Re-examination Study (MK-0518-115)
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|ClinicalTrials.gov Identifier: NCT01042808|
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : July 21, 2015
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.
|Condition or disease|
|HIV Infection HIV Infections|
|Study Type :||Observational|
|Actual Enrollment :||996 participants|
|Official Title:||Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
HIV-1 Infected patients treated with Isentress
- 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 ]
- Proportions of patients with HIV-1 RNA levels of less than 50 milliliter [ Time Frame: 6 months after treatment +/- 2 weeks ]
- Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter [ Time Frame: 6 months after treatment +/- 2 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042808
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|