Stocrin Re-examination Study (0831-028)

July 20, 2015 updated by: Merck Sharp & Dohme LLC

Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN 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 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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

728

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with HIV-1 infection treated with STOCRIN

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with HIV-1 infection taking Stocrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of patients with any adverse experience
Time Frame: Up to 14 days following cessation of treatment
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
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
At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (ESTIMATE)

February 9, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0831-028
  • 2010_008 (OTHER: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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