HIV Infection, HIV Infections
Conditions
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter | 6 months after treatment +/- 2 weeks |
| Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment | up to 14 days after last treatment |
| Proportions of patients with HIV-1 RNA levels of less than 50 milliliter | 6 months after treatment +/- 2 weeks |
| Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible) | 6 months after treatment +/- 2 weeks |
Outcome results
None listed