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A Phase I/II Comparative Pharmacokinetic Study of the Fixed-Dose Combination (FDC) of Stavudine (d4T), Lamivudine (3TC), and Nevirapine (NVP) as GPO-VIR Pediatric Chewable Tablets Versus the Individual Liquid Formulations in HIV Infected Children 6 Months and Older to Less Than 13 Years of Age in Thailand
The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 44 |
| Start date | 2006-12 |
| Completion | 2008-09 |
Conditions
- HIV Infections
Interventions
- Lamivudine, nevirapine, and stavudine fixed-dose tablet
- Lamivudine
- Nevirapine
- Stavudine
Primary outcomes
- Comparative bioavailability — Throughout study
- therapeutic adequacy — Throughout study
Countries
Thailand