Working... Menu
Trial record 6 of 1247 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

Stocrin Re-examination Study (0831-028)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065792
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : July 21, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease
HIV Infection

Layout table for study information
Study Type : Observational
Actual Enrollment : 728 participants
Time Perspective: Prospective
Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of STOCRIN in Usual Practice
Study Start Date : March 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz

Patients with HIV-1 infection taking Stocrin

Primary Outcome Measures :
  1. Percent of patients with any adverse experience [ Time Frame: Up to 14 days following cessation of treatment ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065792

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Layout table for investigator information
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01065792     History of Changes
Other Study ID Numbers: 0831-028
2010_008 ( Other Identifier: Merck )
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers