Phase 3
Completed N=389
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Source: ClinicalTrials.gov NCT00993031 ↗Enrolled (actual)
389
Serious AEs
15.4%
Results posted
Dec 2017
Primary outcomePrimary: Prevalence of Malaria Defined as Positive Placental Blood Smear — 5; 6 participants — p=.76
◆ Published Evidence
Established
51citations · ~4 / year
Maternal nutritional status predicts adverse birth outcomes among HIV-infected rural Ugandan women receiving combination antiretroviral therapy.
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.
Linked Publications (5)
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Maternal nutritional status predicts adverse birth outcomes among HIV-infected rural Ugandan women receiving combination antiretroviral therapy.
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Hair and plasma data show that lopinavir, ritonavir, and efavirenz all transfer from mother to infant in utero, but only efavirenz transfers via breastfeeding.
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Pharmacokinetics of lopinavir/ritonavir and efavirenz in food insecure HIV-infected pregnant and breastfeeding women in Tororo, Uganda.
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Neonatal mortality in HIV-exposed infants born to women receiving combination antiretroviral therapy in Rural Uganda.
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WHO option B+: early experience of antiretroviral therapy sequencing after cessation of breastfeeding and risk of dermatologic toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Malaria Defined as Positive Placental Blood Smear |
5; 6 | .76 |
| PRIMARY Prevalence of Malaria Defined as Positive Placental Blood PCR |
6; 7 | .76 |
| SECONDARY Placental Malaria Defined as Positive Placental RDT |
6; 7 | .45 |
| SECONDARY Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk During Pregnancy |
17; 17 | — |
| SECONDARY Prevalence of Composite Clinical Outcome Defined by LBW, Stillbirth(Intrauterine Fetal Demise >20wks GA), Late Spontaneous Abortion(Miscarriage 12-20wks GA), Preterm Delivery(<37wks Gestation), Neonatal Death(Death of Liveborn Infant Within First 28days) |
33.9; 27.8 | .21 |
| SECONDARY Placental Malaria Defined Placental Histopathologic Analysis |
62; 47 | .06 |
| SECONDARY Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk After Pregnancy |
21; 13 | — |
| SECONDARY Number of Participants With Severe Maternal Anemia Defined by Hemoglobin < 8g/dl at Any Point During the Trial in Each Treatment Group |
11; 11 | — |
| SECONDARY Incidence of Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick |
0; 0 | — |
| SECONDARY Number of Participants With Maternal HIV RNA Suppression of <400 Copies/mL |
166; 153 | — |
| SECONDARY Change in Maternal CD4 Cell Counts |
-7; 57 | — |
| SECONDARY Number of Participants With Maternal to Child Transmission of HIV, Measured by Infant HIV DNA PCR |
0; 2 | — |
| SECONDARY ART Levels in Hair Samples at Delivery |
5.7; 6.6 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Toxicity in the Two Treatment Groups in Women |
12; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 16 years (if 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.
Data sourced from ClinicalTrials.gov (NCT00993031) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.