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

NCT00993031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2019-05-14

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Lopinavir/ritonavir

LPV 200mg/r 50mg

DRUG

Efavirenz

600mg

DRUG

Zidovudine

Zidovudine 300 mg

DRUG

Lamivudine

Lamivudine 150 mg

Sponsors & Collaborators

Principal Investigators

  • Diane Havlir, MD · University of California, San Francisco

  • Deborah Cohan, MD, MPH · University of California, San Francisco

  • Moses R Kamya, MBChB, MMed, PhD · Makerere University

  • Pius Okong, MMed, PhD · Ugandan Ministry of Health

  • Grant Dorsey, MD, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-15
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Uganda

Study Locations

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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 NCT00993031 on ClinicalTrials.gov