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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Infection

• Study Type: Observational
• Enrollment (Actual): 996

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HIV-1 Infected adults

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; HIV-1 Infected patients treated with Isentress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Proportions of patients with HIV-1 RNA levels of less than 50 milliliter	6 months after treatment +/- 2 weeks
Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter	6 months after treatment +/- 2 weeks
Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible)	6 months after treatment +/- 2 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 5, 2010
• First Posted (Estimate): January 6, 2010

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 0518-115; 2010_001 (Other Identifier: Merck)