Status:
COMPLETED
Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Yale University
Makerere University
Conditions:
Drug-Drug Interaction
HIV Infection
Eligibility:
All Genders
3-17 years
Phase:
PHASE4
Brief 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 an...
Detailed Description
The primary goal of the study is to assess the pharmacokinetics (PK) and safety of DP in the setting of co-administration with first-line ART regimens (EFV-, LPV/r- or DTG-based ART) in children witho...
Eligibility Criteria
Inclusion
- 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
- 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 \< 7.0 g/dL
- Current malaria infection or recent treatment with antimalarials within 28 days of
- enrolment.
- Asymptomatic parasitemia detected by microscopy or rapid diagnostic test (RDT)
- History of side effects with DP
- Prior history of cardiac disease (personal or family), baseline corrected QT intervals (QTc) \>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.
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT04487145
Start Date
November 23 2020
End Date
April 11 2022
Last Update
March 14 2025
Active Locations (2)
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1
Masafu General Hospital (MGH) at Busia District, Eastern Uganda
Masafu, Busia, Uganda
2
Baylor-Uganda Center of Excellence on Mulago Hospital Complex and Masafu General Hospital
Kampala, Uganda