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

HIV Infections Clinical Trial

Official title:

Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042808
• Other study ID #: 0518-115
• Secondary ID: 2010_001
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: July 20, 2015
• Start date: May 2011
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 996
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment		up to 14 days after last treatment	Yes
Primary	Proportions of patients with HIV-1 RNA levels of less than 50 milliliter		6 months after treatment +/- 2 weeks	No
Primary	Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter		6 months after treatment +/- 2 weeks	No
Primary	Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible)		6 months after treatment +/- 2 weeks	No