Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 996
- Primary Endpoint
- Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment
Study Overview
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 Isentress through collecting the safety and efficacy information in usual practice 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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV-1 Infected Adults
- •Treated with Isentress 400 mg tablet within local label during the enrollment period
Exclusion Criteria
- •Contraindication to Isentress according to the local label
Outcomes
Primary Outcomes
Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment
Time Frame: up to 14 days after last treatment
Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible)
Time Frame: 6 months after treatment +/- 2 weeks
Proportions of patients with HIV-1 RNA levels of less than 50 milliliter
Time Frame: 6 months after treatment +/- 2 weeks
Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter
Time Frame: 6 months after treatment +/- 2 weeks
Secondary Outcomes
No secondary outcomes reported