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Isentress Re-examination Study (MK-0518-115 AM1)

This study is currently recruiting participants.
Verified June 2012 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01042808
First received: January 5, 2010
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  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.


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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment: 3000
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042808

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Illinois
Call for Information (Investigational Site 9001) Recruiting
Peoria, Illinois, United States, 61603
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01042808     History of Changes
Other Study ID Numbers: 0518-115, 2010_001
Study First Received: January 5, 2010
Last Updated: June 15, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
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 May 19, 2013