Phase 3
N=200
Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)
Malaria · Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT02282293 ↗Enrolled (actual)
200
Serious AEs
5.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants With Placental Malaria — 3; 6 Participants — p=0.50
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS) (Drug); Monthly placebo + daily trimethoprim/sulfamethoxazole (TS) (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Placental Malaria |
3; 6 | 0.50 |
| PRIMARY Incidence of Malaria, Pregnant Women |
0.03; 0.00 | — |
| SECONDARY Maternal Parasitemia at Delivery by Microscopy and LAMP |
0; 1; 2; 4 | 0.50 |
| SECONDARY Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR) |
0; 1; 1; 3 | — |
| SECONDARY Number of Monthly Routine Visits With Positive Blood Samples for Parasites |
12; 5 | 0.19 |
| SECONDARY Composite Adverse Birth Outcome (Proportion With Low Birth Weight (<2500 gm), Spontaneous Abortion (<28 Weeks), Stillbirth (Fetal Demise ≥28 Weeks), Congenital Anomaly, or Preterm Delivery (<37 Weeks) |
15; 20 | 0.35 |
| SECONDARY Number of Routine Visits Measured Every 8 Weeks During Pregnancy for Which the Participants Had Anemia |
65; 51 | — |
Summary
This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women between 12 and 28 weeks gestation will be randomized to receive enhanced malaria chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo. Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of age to which the mothers were randomized. All women will receive daily trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be considered a study drug only in infants and children beginning 6 weeks after cessation of breastfeeding and upon exclusion of HIV infection. Women and their children will be followed for 36 months after delivery. In a subset of the study population, the investigators will conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in the study. The investigators will test the hypothesis that for HIV-infected mothers and HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected pregnant women and their children will reduce the incidence of malaria among children from 0 to 24 months of age and improve the development of naturally acquired antimalarial immunity.
Eligibility Criteria
Inclusion Criteria
- Intrauterine pregnancy confirmed by ultrasound
- Estimated gestational age between 12-28 weeks
- Confirmed to be HIV-infected by Uganda country standard rapid HIV test
- 16 years of age or older
- Residency within 30 km of the study clinic
- Provision of informed consent
- Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
- Plan to deliver in the hospital
Exclusion Criteria
- History of serious adverse event to TS or DP
- Refusal to take cART during pregnancy or as part of routine HIV care
- Active medical problem requiring inpatient evaluation at the time of screening
- Intention of moving more than 30 km from the study clinic
- Active WHO stage 4 condition not stable under treatment
- Signs or symptoms of early or active labor
- Currently on ritonavir
- Currently taking drugs associated with known risk of Torsades de pointes
- Currently taking CYP3A inhibitor medications which potentially inhibit the metabolism of piperaquine
- History of cardiac problems or fainting
Data sourced from ClinicalTrials.gov (NCT02282293). 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.