Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Isentress Re-examination Study (MK-0518-115)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01042808
First received: January 5, 2010
Last updated: July 29, 2014
Last verified: July 2014

January 5, 2010
July 29, 2014
May 2011
May 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01042808 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Isentress Re-examination Study (MK-0518-115)
Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

HIV-1 Infected adults

  • HIV Infection
  • HIV Infections
Not Provided
1
HIV-1 Infected patients treated with Isentress
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
996
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01042808
0518-115, 2010_001
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP