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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042808
First Posted: January 6, 2010
Last Update Posted: July 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
January 5, 2010
January 6, 2010
July 21, 2015
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 ]
  • 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 ]
  • 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 and 400 copies per milliliter at 6-month after treatment, change from baseline to treatment in CD4 cell count and overall efficacy evaluation by investigator [ Time Frame: At 6-month after treatment ]
Complete list of historical versions of study NCT01042808 on ClinicalTrials.gov Archive Site
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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.

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Observational
Time Perspective: Prospective
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Probability Sample
HIV-1 Infected adults
  • HIV Infection
  • HIV Infections
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1
HIV-1 Infected patients treated with Isentress
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*   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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
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Korea, Republic of,   United States
 
NCT01042808
0518-115
2010_001 ( Other Identifier: Merck )
No
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2015