HIV-1
Conditions
Brief summary
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly
Interventions
DRUGNo Intervention
Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA
Exclusion criteria
* According to Warning/Caution in local label
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events occurrence | 30 days after last dose of study drug | Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration | Baseline and 16 weeks after first treatment | — |
| CD 4 T-cell count before and after drug administration | Baseline and 16 weeks after first treatment | — |
| Overall efficacy evaluation by investigator's discretion | Baseline and 16 weeks after first treatment | Based on laboratory test results including HIV RNA (viral load) and CD4 T-cell count, clinical findings, subjective findings and objective findings in comparison to baseline |
Countries
South Korea
Outcome results
None listed