Status:
COMPLETED
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Malaria
HIV Infections
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief 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 breastfeedi...
Detailed Description
The study site will be the Tororo district hospital campus situated in Eastern Uganda, an area of high malaria transmission. Using convenience sampling, we will enroll 500 HIV-infected pregnant women ...
Eligibility Criteria
Inclusion
- Age \> 16 years (if \<18 years old, living independently from parents)
- Documentation of HIV status must come from two assays. Assays include DNA PCR, HIV RNA, Western blot, or rapid HIV antibody test
- Confirmed pregnancy by positive serum or urine pregnancy test or ultrasound
- 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
- Residency within 30 km of the study site
- Willing to provide informed consent
Exclusion
- Current or prior use of HAART
- 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
- Prior dose-limited toxicity to TS within 14 days of study enrollment
- Receipt of any contraindicated medications within 14 days of study enrollment (See Appendix III.)
- Active tuberculosis or other WHO Stage 4 diseases
- Screening laboratory values:
- 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.)
- Absolute neutrophil count (ANC): \<750/mm3
- Platelet count: \<50,000/mm3
- ALT: \>225 U/L (\>5.0x ULN)
- AST: \>225 U/L (\>5.0x ULN)
- Bilirubin (total): \> 2.5x ULN
- Creatinine: \> 1.8x ULN
- 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.
Key Trial Info
Start Date :
December 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00993031
Start Date
December 15 2009
End Date
July 1 2013
Last Update
May 14 2019
Active Locations (1)
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1
Tororo District Hospital
Tororo, Uganda