Stocrin Re-examination Study (0831-028)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: February 8, 2010
Last updated: July 20, 2015
Last verified: July 2015

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.

HIV Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 728
Study Start Date: March 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Patients with HIV-1 infection taking Stocrin


Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HIV-1 infection treated with STOCRIN

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01065792

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01065792     History of Changes
Other Study ID Numbers: 0831-028  2010_008 
Study First Received: February 8, 2010
Last Updated: July 20, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HIV Infection

Additional relevant MeSH terms:
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases processed this record on May 30, 2016