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

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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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
Proportions of patients with HIV-1 RNA levels of less than 50 milliliter

Time frame: 6 months after treatment +/- 2 weeks
Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter

Time frame: 6 months after treatment +/- 2 weeks
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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jan 6, 2010
Registry last updated: Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed