Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)
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|ClinicalTrials.gov Identifier: NCT02282293|
Recruitment Status : Completed
First Posted : November 4, 2014
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malaria Human Immunodeficiency Virus||Drug: Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS) Drug: Monthly placebo + daily trimethoprim/sulfamethoxazole (TS)||Phase 3|
Pregnant women will be scheduled to be seen in the study clinic every 4 weeks during their pregnancy. Women will be seen at 1 week, 6 weeks, and 3 months postpartum and every 3 months thereafter. In addition, pregnant women will be instructed to come to the study clinic for all their medical care and avoid the use of any outside medications. Women will be provided all routine HIV care at the clinic according to Uganda MOH guidelines. All women will have ARVs and TS dispensed at the study clinic. Counseling on breastfeeding and infant feeding will be provided per Uganda MOH guidelines. HIV care and breastfeeding and infant feeding recommendations may be changed to reflect the most recent standard of care per MOH guidelines. Children will be scheduled to be seen in the clinic every 4 weeks and parents /guardians of children will be instructed to bring their child to the study clinic for all medical care and avoid the use of any outside medications. The study clinic will remain open 7 days a week from 8 a.m. to 5 p.m.
Each time a study participant is seen in the clinic a standardized history and physical exam will be performed. Patients who are febrile (tympanic temperature > 3 8.0˚C) or report history of fever in the past 24 hours will have blood obtained by finger prick for a thick blood smear. If the thick blood smear is positive, the patient will be diagnosed with malaria. If the thick blood smear is negative, the patient will be managed by study physicians for a non-malarial febrile illness. If the patient is afebrile and does not report a recent fever, a thick blood smear will not be obtained, except when following routine testing schedules.
Routine assessments will be done in the clinic every 4 weeks for both pregnant women and children. Pregnant women and children will receive standards of care as designated in the Uganda MOH guidelines. Children will have care for HIV-exposed children according to MOH guidelines, with the exception that TS will be continued until 2 years of life. Routine care in children will use Integrated Management of Childhood Illness (IMCI) guidelines. During routine assessments subjects will be asked about visits to outside health facilities and the use of any medications outside the study protocol. Standardized assessment of adherence will also be done for study drugs administered at home and Insecticide Treated Net use. A routine history and physical exam will be performed using a standardized clinical assessment form. Blood will be collected by finger prick for thick smear, collection of plasma for PK studies, and filter paper samples. Phlebotomy for routine laboratory tests (CBC and ALT) to monitor for potential adverse events from study medications and for immunology studies will be performed every 8 weeks in pregnant women. Non malaria screening will also include stool ova and parasite examination, circulating filarial antigens (by ICT card for Wucheria), and blood smear for microfilaremia (including Mansonella perstans) using Knott's technique. For pregnant women, study drugs will be administered at the time of each routine visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE Birth Cohort 2)|
|Actual Study Start Date :||December 9, 2014|
|Actual Primary Completion Date :||May 26, 2016|
|Actual Study Completion Date :||May 26, 2016|
Active Comparator: Daily TS + Monthly DP pregnancy
Women will be given DP (3 full strength tabs, 40 mg/320 mg, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregancy, TS will be given to women at a dose of 960mg once daily.
Drug: Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS)
Other Name: Duo-Cotexin (Holley-Cotec)
Placebo Comparator: Daily TS + DP Placebo pregnancy
Women will be given DP placebo (3 tabs, given once a day for 3 consecutive days) every 4 weeks during pregnancy. During pregnancy, TS will be given to women at a dose of 960mg once daily.
Drug: Monthly placebo + daily trimethoprim/sulfamethoxazole (TS)
- Number of Participants With Placental Malaria [ Time Frame: at delivery estimated to be within 10 to 30 weeks of study entry ]The primary outcome will be the prevalence of placental malaria based on placental histopathology and dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence of placental infection.
- Incidence of Malaria, Pregnant Women [ Time Frame: Time at risk will begin following administration of first dose of study drug to delivery ]The primary outcome will be the incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days.
- Maternal Parasitemia at Delivery by Microscopy and LAMP [ Time Frame: At delivery ]Proportion of women with parasitemia detected by microscopy or LAMP at delivery
- Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR) [ Time Frame: At delivery ]Proportion of placental blood samples positive for malaria by microscopy or PCR
- Number of Monthly Routine Visits With Positive Blood Samples for Parasites [ Time Frame: Following administration of first dose of study drug to delivery ]Proportion of monthly routine blood samples positive by LAMP for parasites
- 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) [ Time Frame: At delivery ]Proportion with low birth weight (<2500 gm), spontaneous abortion (<28 weeks), stillbirth (fetal demise ≥28 weeks), congenital anomaly, or preterm delivery (<37 weeks)
- Number of Routine Visits Measured Every 8 Weeks During Pregnancy for Which the Participants Had Anemia [ Time Frame: Following administration of first dose of study drugs to delivery ]Anemia (hemoglobin less than 11g/dL) measured every 8 weeks during pregnancy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282293
|IDRC Research Clinic - Tororo District Hospital|
|Principal Investigator:||Diane V Havlir, MD||University of California, San Francisco|
|Principal Investigator:||Grant Dorsey, MD, PhD||University of California, San Francisco|
|Principal Investigator:||Moses R Kamya, MBChB, MMed, PhD||Makerere University; Infectious Diseases Research Collaboration|