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Pharmacology of Artemisinin-Based Antimalarial Therapy Within the Context of Antiretroviral Therapy
The purpose of this study is to see if taking nevirapine (NVP) for HIV changes the way artemether/lumefantrine (AL) works in children who are co-infected with both HIV and malaria. The brand of AL used in this study is Coartem® Dispersible. This study will compare the blood levels of AL in co-infected children who already take NVP prescribed by their doctor with the co-infected children who do not take anti HIV medicines because they do not meet national guidelines to start them. The study will also assess the safety of using both medications (AL and NVP) in children.
Details
| Lead sponsor | International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 19 |
| Start date | 2012-02 |
| Completion | 2014-03 |
Conditions
- HIV Infection
- Malaria
Interventions
- Artemether/Lumefantrine (AL)
Primary outcomes
- Area under the curve from time zero to last quantifiable concentration (AUC) — NVP PK: At study entry and study day 3, AL PK: At study days 3, 4, 8, and 14
Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration - Toxicity — At study entry and study days 28 and 42
Number of subjects with adverse events of Grade 3 or higher will be recorded - Maximum observed plasma concentration (Cmax) — NVP PK: At study entry and study day 3, AL PK: At study days 3, 4, 8, and 14
Maximum observed plasma concentration computed for each individual and then summarized for the strata - Minimum observed plasma concentration (Cmin) — NVP PK: At study entry and study day 3, AL PK: At study days 3, 4, 8, and 14
Minimum observed plasma concentration computed for each individual and then summarized for the strata - Toxicity — At study days 28 and 42
Percentage of subjects with adverse events of Grade 3 or higher will be recorded Safety Issue: Yes
Countries
Malawi, Uganda