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

NCT ID: NCT01042808

Last Updated: 2015-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

996 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-05-31

Brief Summary

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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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Detailed Description

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Conditions

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HIV Infection HIV Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

HIV-1 Infected patients treated with Isentress

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2010_001

Identifier Type: OTHER

Identifier Source: secondary_id

0518-115

Identifier Type: -

Identifier Source: org_study_id

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