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Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy

NCT04487145 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-03-14

Study results available
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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.

Conditions

  • Drug-Drug Interaction
  • HIV Infection

Interventions

DRUG

Dihydroartemisinin-piperaquine

It is expected that efavirenz (EFV), lopinavir/ritonavir (LPV/r), and/or dolutegravir (DTG) will alter DP exposure.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Francesca Aweeka · University of California, San Francisco

  • Sunil Parikh · Yale University

  • Norah Mwebaza · Makerere University

  • Adeodata Kekitiinwa · Baylor College of Medicine Children's foundation Uganda

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2022-04-11
Completion
2022-04-11

Countries

  • Uganda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04487145 on ClinicalTrials.gov