EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY IN HIV+ PATIENTS
Not Applicable
- Conditions
- HIV/AIDSMalariaPregnancy and Childbirth
- Registration Number
- PACTR2010020001813440
- Lead Sponsor
- FCRB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Female
- Target Recruitment
- 0
Inclusion Criteria
Trial 2:
Permanent resident in the area.
Gestational age at the first antenatal visit < 28 weeks
HIV seropositive (after voluntary counseling and testing)
Indication to receive CTX prophylaxis (according to the national guidelines)
Signed informed consent
Agreement to deliver in the study site's maternity wards
Exclusion Criteria
Trial 2:
Residence outside the study area or planning to move out in the following 10 months from enrollment
Gestational age at the first antenatal visit > 28 weeks of pregnancy
Known history of allergy to CTX or MQ
Known history of severe renal, hepatic, psychiatric or neurological disease
MQ or halofantrine treatment in the preceding 4 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peripheral parasitemia at delivery
- Secondary Outcome Measures
Name Time Method Maternal anemia at delivery;Perinatal mortality;Neonatal mortality;Number of stillbirths;Incidence of clinical malaria during pregnancy;Mean maternal hemoglobin rate g/dL;Prevalence of P.falciparum parasitemia in cord blood ;Incidence of overall admissions/outpatient attendances;Prevalence of congenital malaria;Mean birth weight;Frequency of drug adverse reactions;Frequency of congenital malformations;Prevalence of placental P.Falciparum infection;Prevalence low birth weight babies;Prevalence of fetal anemia;Prevalence of preterm babies;Mean of CD4 count and viral load