Clinical trialNCT00993031CompletedPhase 3Interventional

Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women

SponsorUniversity of California, San FranciscoEnrollment389HIV InfectionsMalaria

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria. This study also enrolls the infants of these women at the time of delivery.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Deborah Cohan, MD, MPH
University of California, San Francisco
Study Chair
clinicaltrials.gov ↗
Diane Havlir, MD
University of California, San Francisco
Principal Investigator
clinicaltrials.gov ↗
Grant Dorsey, MD, PhD
University of California, San Francisco
Principal Investigator
clinicaltrials.gov ↗
Moses R Kamya, MBChB, MMed, PhD
Makerere University
Principal Investigator
clinicaltrials.gov ↗
Pius Okong, MMed, PhD
Ugandan Ministry of Health
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Uganda

Tororo District Hospital
Tororo, Uganda

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Efavirenz →Lamivudine →Lopinavir →Zidovudine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Dec 2009
Primary completion: 31 Jul 2013
Completion: 31 Jul 2013
Last update posted: 14 May 2019
Registered enrollment: 389
Registry id: NCT00993031

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.