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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Efavirenz; HIV Protease Inhibitors; Lamivudine; Lopinavir; Protease Inhibitors; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

1. Age > 16 years (if <18 years old, living independently from parents)

2. Documentation of HIV status must come from two assays. Assays include DNA PCR, HIV RNA, Western blot, or rapid HIV antibody test

3. Confirmed pregnancy by positive serum or urine pregnancy test or ultrasound

4. Estimated gestational age between 12 and 28 weeks (based on first day of last menstrual period with physical exam confirmation and ultrasound confirmation) at time of enrollment

5. Residency within 30 km of the study site

6. Willing to provide informed consent

Exclusion Criteria:

1. Current or prior use of HAART

2. Exposure to single-dose NVP (alone or with zidovudine or zidovudine/lamivudine or other abbreviated monotherapy or dual therapy for PMTCT) less than 24 months prior to enrollment

3. Prior dose-limited toxicity to TS within 14 days of study enrollment

4. Receipt of any contraindicated medications within 14 days of study enrollment (See Appendix III.)

5. Active tuberculosis or other WHO Stage 4 diseases

6. Screening laboratory values:

1. Hemoglobin: <7.5 g/dL (Note: Women found to have a hemoglobin <7.5 at screening may receive iron and folic acid and/or a blood transfusion at the physician's discretion. If a repeat hemoglobin is ≥7.5 g/dL, the woman may be considered for study inclusion.)

2. Absolute neutrophil count (ANC): <750/mm3

3. Platelet count: <50,000/mm3

4. ALT: >225 U/L (>5.0x ULN)

5. AST: >225 U/L (>5.0x ULN)

6. Bilirubin (total): > 2.5x ULN

7. Creatinine: > 1.8x ULN

7. Known cardiac conduction abnormalities or structural heart defect

NOTE: A woman will be excluded from study participation during the current pregnancy if she goes into labor, experiences ruptured membranes or develops active tuberculosis or a WHO stage 4 condition following study enrollment but prior to study drug initiation.