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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
  Purpose

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.


Condition
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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment: 600
Study Start Date: March 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with HIV-1 infection taking Stocrin

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065792

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Yong Soo (STEVE) Kim     82 2 331 2014        
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01065792     History of Changes
Other Study ID Numbers: 0831-028, 2010_008
Study First Received: February 8, 2010
Last Updated: March 22, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck:
HIV Infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013