HIV Infections Clinical Trial
Official title:
Prevention of Pregnancy-associated Malaria in HIV-infected Women : Randomised Controlled Trial Testing Cotrimoxazole Prophylaxis Versus Intermittent Preventive Treatment With Mefloquine
The purpose of this study is to evaluate the efficacy of cotrimoxazole prophylaxis in prevention of malaria during pregnancy in HIV-infected women, compared to intermittent preventive treatment with mefloquine.
Malaria infection during pregnancy can have adverse effects on both mother and fetus,
including maternal anaemia and low birth weight which are responsible for mother and infant
mortality. It is a particular problem for women in their first and second pregnancies and
for women who are HIV-positive. Maternal HIV infection potentiates many of these adverse
effects. In HIV-infected women, the World Health Organization (WHO) advocates the use of
insecticide-treated bednets, and drugs : If the CD4 cell count is below 350/mm3 or the HIV
disease is in WHO stage 2, 3 or 4, cotrimoxazole prophylaxis for the prevention of
pneumocystosis and toxoplasmosis is indicated, that is assumed to also protect those women
from malaria. Otherwise, they have to receive at least three doses of intermittent
preventive treatment (IPT), most commonly with sulfadoxine-pyrimethamine (SP) given at the
antenatal care visits. If IPT with SP has been a subject of many investigations,
cotrimoxazole efficacy has never been assessed in prevention of malaria during pregnancy.
The investigators aim to evaluate the efficacy of cotrimoxazole prophylaxis in prevention of
malaria during pregnancy in HIV-infected women. The investigators postulate that
cotrimoxazole prophylaxis is not inferior to IPT in all women, unrelated to their CD4 cell
count. In the control arm, the investigators will use mefloquine as IPT. The safety and
efficacy of this drug have already been assessed in HIV-negative patients (NCT00274235).
A randomized controlled trial will be conducted in five hospitals in Benin. Pregnant women
will be enrolled both in the Antenatal Care unit and in the Infectious Diseases unit of each
setting. All women will receive insecticide-treated bednets at enrolment. Randomization will
be stratified by hospital and CD4 cell count range. Women assigned to cotrimoxazole will
receive cotrimoxazole prophylaxis daily during all the course of pregnancy. Women assigned
to mefloquine IPT will receive mefloquine three times during pregnancy. Women randomised in
this arm and having a low CD4 cell count or an advanced HIV disease will also receive
cotrimoxazole prophylaxis in prevention of HIV/AIDS opportunistic infections. Drug efficacy
will be judged on the prevalence of placental malaria at delivery.
This study will contribute to updating the recommendations concerning the prevention of
malaria during pregnancy in HIV-infected women.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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