EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY IN HIV+ PATIENTS

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2010020001813440
• Date of registration: 23/12/2009
• Primary sponsor: FCRB
• Public title: EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY IN HIV+ PATIENTS
• Scientific title: EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY IN HIV+ PATIENTS
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010020001813440
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation using a radomisation table created by a computer software program ,; Sealed opaque envelopes ,

Countries of recruitment

South Africa

Contacts

• Name: Raquel Gonzalez
• Affiliation: Epidemiologist

• Name: Golbahar Pahlavan
• Affiliation: Project Manager

Key inclusion & exclusion criteria

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 b 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

Age minimum: 15 Year
Age maximum: 50 Year
Gender: Female

Health Condition(s) or Problem(s) studied

HIV/AIDS
Malaria
null

Primary Outcome(s)

Peripheral parasitemia at delivery

Secondary Outcome(s)

Frequency of congenital malformations

Frequency of drug adverse reactions

Incidence of clinical malaria during pregnancy

Incidence of overall admissions/outpatient attendances

Maternal anemia at delivery

Mean birth weight

Mean maternal hemoglobin rate g/dL

Mean of CD4 count and viral load

Neonatal mortality

Number of stillbirths

Perinatal mortality

Prevalence low birth weight babies

Prevalence of congenital malaria

Prevalence of fetal anemia

Prevalence of P.falciparum parasitemia in cord blood

Prevalence of placental P.Falciparum infection

Prevalence of preterm babies

Secondary ID(s)

EDCTP IP.07.31080.002

NCT00811421

Source(s) of Monetary Support

EDCTP

Malaria in Pregnancy Consortium