Stocrin Re-examination Study (0831-028)

Merck Sharp & Dohme LLC728 enrolled

Overview

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 STOCRIN through collecting the safety and efficacy information 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 Type

OBSERVATIONAL

Enrollment

728

Conditions

HIV Infection

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-1 Infected Patient * Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.) Exclusion Criteria: * Patient Who Has A Contraindication To Stocrin According To The Local Label

Outcomes

Primary Outcomes

Percent of patients with any adverse experience

Time frame: Up to 14 days following cessation of treatment

Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment

Time frame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment

Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)

Time frame: At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment

Data from ClinicalTrials.gov

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