Two-dose versus monthly intermittent preventive treatment of malaria with sulfadoxine-pyrimethamine in HIV-seropositive pregnant Zambian women.
BACKGROUND
Intermittent preventive treatment of malaria during pregnancy (IPTp) reduces placental infection, maternal anemia, and low birth weight (LBW). However, the optimal dosing regimen in settings in which human immunodeficiency virus (HIV) is highly prevalent among pregnant women remains controversial.


METHODS
We conducted a randomized, double-blind, placebo-controlled study of IPTp comparing the standard 2-dose sulfadoxine-pyrimethamine (SP) regimen with monthly IPTp among a cohort of HIV-positive pregnant Zambian women. Primary outcomes included placental malaria (by smear and histology) and maternal peripheral parasitemia at delivery.


RESULTS
There were no differences between monthly IPTp (n=224) and standard IPTp (n=232) in placental malaria by histopathology (26% vs. 29%; relative risk [RR], 0.90 [95% confidence interval {CI}, 0.64-1.26]) or placental parasitemia (2% vs. 4%; RR, 0.55 [95% CI, 0.17-1.79]). There also were no differences in maternal anemia, stillbirths, preterm delivery, LBW, or all-cause mortality of infants at 6 weeks.


CONCLUSIONS
In an area of mesoendemicity in Zambia, monthly SP IPTp was not more efficacious than the standard 2-dose regimen for the prevention of placental malaria or adverse birth outcomes. IPTp policy recommendations need to take into account local malaria transmission patterns and the prevalence of HIV.


BACKGROUND
ClinicalTrials.gov identifier: NCT00270530.
Hamer
Davidson H
DH
Center for International Health and Development, Boston University School of Public Health, Boston, MA 02118, USA. dhamer@bu.edu
Mwanakasale
Victor
V
Macleod
William B
WB
Chalwe
Victor
V
Mukwamataba
Doreen
D
Champo
Davies
D
Mwananyanda
Lawrence
L
Chilengi
Roma
R
Mubikayi
Lwambwa
L
Mulele
Chikuli Kabika
CK
Mulenga
Modest
M
Thea
Donald M
DM
Gill
Christopher J
CJ
D017088:AIDS-Related Opportunistic Infections / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D000328:Adult; D000740:Anemia / Q000139:chemically induced; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects*; D001724:Birth Weight; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005312:Fetal Blood / Q000469:parasitology; D006679:HIV Seropositivity; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D015994:Incidence; D016778:Malaria, Falciparum / Q000453:epidemiology / Q000517:prevention & control*; D016017:Odds Ratio; D018512:Parasitemia / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D010920:Placenta / Q000469:parasitology; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D011256:Pregnancy Outcome; D011739:Pyrimethamine / Q000008:administration & dosage* / Q000009:adverse effects*; D012307:Risk Factors; D013413:Sulfadoxine / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome; D015024:Zambia / Q000453:epidemiology
D000962:Antimalarials; D004338:Drug Combinations; D006454:Hemoglobins; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine