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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: HIV Infection; HIV Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT01042808

0518-115

2010_001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 996 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

996 participants in 1 patient group

1

Description:

HIV-1 Infected patients treated with Isentress