Antimalarial Pharmacology in Children and Pregnant Women in Uganda (NCT01717885) | Clinical Trial Compass
CompletedNot Applicable
Antimalarial Pharmacology in Children and Pregnant Women in Uganda
Uganda473 participantsStarted 2012-08
Plain-language summary
The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa. Malaria is one of the most important infectious diseases in the world. Uganda reports among the highest transmission intensities in the world. Children and pregnant women are the most vulnerable populations. HIV is also reported at high rates for these populations. If malaria and HIV require treatment at the same time, there is a high risk for drug-drug interactions. This study will:
1. Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r), nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment for uncomplicated malaria in HIV-infected children and pregnant women, and
2. Evaluate the impact of age and pregnancy on the PK exposure of AL.
Who can participate
Age range6 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Residency within 60 km of the study clinic
✓. Agreement to come to clinic for all follow-up clinical and PK evaluations
✓. Provision of informed consent
✓. 6 months to 8 years of age
✓. Weight ≥6 kg
✓. Confirmed HIV infection (positive rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)
✓. On a stable ART regimen for at least 10 days prior to enrollment
✓. If co-enrolled from PROMOTE, willingness to undergo intensive PK sampling during a single episode of uncomplicated malaria, and/or population PK/parasite clearance time studies during multiple episodes of uncomplicated malaria.
Exclusion criteria
✕. History of significant comorbidities such as malignancy, active tuberculosis or other WHO stage 4 disease
✕
What they're measuring
1
Primary outcome measurement is the area under the plasma concentration versus time curve for all drug analytes.
Timeframe: At time of the last dose of a 6 dose regimen and up to 42 days of F/U
✕. Receipt of any medications known to affect cytochrome p450 (CYP450) metabolism (except ART) within 14 days of study enrollment (see 4.2.2)
✕. Hemoglobin \< 7.0 g/dL
✕. Prior treatment for malaria within 14 days of study enrollment (intensive PK study participants only)
✕. Signs or evidence of complicated malaria, defined as unarousable coma OR ANY TWO OF THE FOLLOWING SYMPTOMS: Recent febrile convulsions, altered consciousness, lethargy, unable to drink, unable to stand/sit due to weakness, severe anemia (Hb \< 5.0 gm/dL), respiratory distress, jaundice