Stocrin Re-examination Study (0831-028)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01065792

Enrollment

728

Registered

2010-02-09

Start date

2009-03-31

Completion date

2014-02-28

Last updated

2015-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV Infection

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percent of patients with any adverse experience	Up to 14 days following cessation of treatment
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
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

Outcome results