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
  Purpose

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
HIV Infection
HIV Infections

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 996
Study Start Date: May 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HIV-1 Infected patients treated with Isentress

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV-1 Infected adults

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042808

Locations
Korea, Republic of
MSD Korea LTD
Seoul, Korea, Republic of
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01042808     History of Changes
Other Study ID Numbers: 0518-115, 2010_001
Study First Received: January 5, 2010
Last Updated: July 29, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014