Phase 4
N=40
Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy
Drug-Drug Interaction · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT04487145 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: AUC0-42day in 3-dose Study — 4.47; 14.9; 49.7; 14.6 hr.ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dihydroartemisinin-piperaquine (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-42day in 3-dose Study |
4.47; 14.9; 49.7; 14.6; 19.2 | — |
| PRIMARY QTcF in 3-dose Study |
0; 3; 8; 2; 2 | — |
| PRIMARY AUC0-day28 in 3-dose Study |
4.33; 12.7; 41.6; 12.5; 16.4 | — |
| PRIMARY Cmax for Piperaquine in 3-dose Study |
243; 285; 491; 218; 272 | — |
Summary
Open-label prospective intensive pharmacokinetic study of dihydroartemisinin-piperaquine (DP) in HIV-infected children on efavirenz (EFV)-, lopinavir/ritonavir (LPV/r)-, or dolutegravir (DTG)-based antiretroviral therapy (ART) and HIV-uninfected children not on ART. All children will be malaria-uninfected at the time of enrollment.
Eligibility Criteria
Inclusion Criteria
All participants:
- Agreement to come to clinic for all follow-up PK and safety evaluations
- Provision of informed consent.
HIV-infected participants:
- Residency within 30km of Mulago Hospital.
- Confirmed HIV infection (confirmed positive rapid HIV test or HIV RNA as per
- Ugandan guidelines).
- On stable EFV-, LPV/r- or DTG-based ART for at least 10 days prior to enrollment.
- Age 3 - 10 years if on EFV-based ART or LPV/r-based ART.
- Age 11 - 17 years if on DTG-based ART.
HIV-uninfected participants:
- Residency within 30km of Masafu General Hospital
- Confirmed HIV negative test (confirmed positive rapid HIV test or HIV RNA as
- per Ugandan guidelines)
- Age 3 - 17 years.
Exclusion Criteria
- History of significant comorbidities such as malignancy, active tuberculosis or
- other active WHO stage 4 disease
- Receipt of any medications known to affect CYP450 metabolism (except ART)
- within 14 days of study enrolment (see 4.2.1)
- Hemoglobin 450msec, or
- receipt of any cardiotoxic drugs or those known to prolong QT intervals History of
- significant comorbidities such as malignancy, active tuberculosis or other WHO
- stage 4 disease
- Weight < 6kg
- HIV-infected females on DTG-based ART and age 13-17 years who are pregnant
- or of childbearing potential and do not agree to consistent and reliable
- contraception.
The following medications are disallowed within 3 weeks prior to receiving study drug:
- Carbamazepine
- Clarithromycin
- Erythromycin (oral)
- Ketoconazole
- Phenobarbital
- Phenytoin
- Rifabutin
- Rifampicin
- Halofantrine
- Any other medication known to significantly affect CYP450 metabolism.
- Grapefruit juice should be avoided during the study due to its potential effects on CYP3A4.
Data sourced from ClinicalTrials.gov (NCT04487145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.