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Antimalarial Pharmacology in Children and Pregnant Women in Uganda

NCT01717885 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 473

Last updated 2024-10-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Francesca T Aweeka, Pharm.D. · University of California, San Francisco

  • Sunil Parikh, MD MPH · Yale University

  • Norah Mwebaza, MBChB, MSc · Makerere University

  • Myaing Nyunt, MD PhD · Johns Hopkins University

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-12-31
Completion
2016-09-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases
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 NCT01717885 on ClinicalTrials.gov