Stocrin Re-examination Study (0831-028)

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065792
• Other study ID #: 0831-028
• Secondary ID: 2010_008
• Status: Completed
• Phase: N/A
• First received: February 8, 2010
• Last updated: July 20, 2015
• Start date: March 2009
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 728
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients with any adverse experience		Up to 14 days following cessation of treatment	Yes
Primary	Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment		At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment	No
Primary	Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed)		At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment	No