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Stocrin Re-examination Study (0831-028 AM1)

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01065792
First received: February 8, 2010
Last updated: March 22, 2013
Last verified: March 2013
History of Changes

February 8, 2010
March 22, 2013
March 2009
August 2014   (final data collection date for primary outcome measure)
  • Percent of patients with any adverse experience [ Time Frame: Up to 14 days following cessation of treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065792 on ClinicalTrials.gov Archive Site
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Stocrin Re-examination Study (0831-028 AM1)
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.
Not Provided
Observational
Time Perspective: Prospective
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Probability Sample

Patients with HIV-1 infection treated with STOCRIN
HIV Infection
Not Provided
1
Patients with HIV-1 infection taking Stocrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
3 Years and older
No
Contact: Toll Free Number 1-888-577-8839
Korea, Republic of
 
NCT01065792
0831-028, 2010_008
No
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP