Cotrimoxazole Prophylaxis Versus Mefloquine Intermittent Preventive Treatment to Prevent Malaria in HIV-Infected Pregnant Women

Nov 14, 2013Journal of acquired immune deficiency syndromes (1999)

Comparing Cotrimoxazole and Mefloquine Treatments to Prevent Malaria in Pregnant Women with HIV

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Abstract

At delivery, 0% of women receiving mefloquine (MQ) experienced placental malaria infection compared to 5% in the cotrimoxazole (CTX) alone group.

Cotrimoxazole alone showed noninferiority in preventing placental malaria compared to the standard treatment of mefloquine.
A significant reduction in placental malaria infection was observed when cotrimoxazole was combined with mefloquine (0/105 vs. 5/103).
Moderate dizziness and vomiting were reported in 34%-37% of women receiving mefloquine, while these symptoms were minimal in the cotrimoxazole groups (0%-3%).
No serious adverse events related to the drugs were identified during the trials.
Insufficient recruitment in the CTX-not-mandatory trial limited the ability to assess noninferiority conclusively.

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BACKGROUND: Malaria during pregnancy has serious consequences that are worsened by HIV infection. Malaria preventive measures for HIV-infected pregnant women include cotrimoxazole (CTX) prophylaxis given to prevent HIV-related opportunistic infections and also protective against malaria, or intermittent preventive treatment (IPTp) with an antimalarial drug. Here, we present the first study evaluating CTX efficacy versus mefloquine (MQ)-IPTp, alone and in combination, in HIV-infected pregnant women.

METHODS: We conducted 2 randomized, open-label, noninferiority trials in Benin. In the CTX-mandatory trial, HIV-infected women with CD4 counts of <350 per cubic millimeter received CTX either alone or with MQ-IPTp (N = 292). In the CTX-not-mandatory trial (CD4 count >350/mm), CTX was compared with MQ-IPTp (N = 140). In both the trials, the primary end point was microscopic placental parasitemia.

RESULTS: At delivery, 1 woman in each CTX-alone treatment group exhibited placental parasitemia, versus no women in the groups receiving MQ. CTX alone demonstrated noninferiority in the CTX-mandatory trial. However, polymerase chain reaction-detected placental parasitemia was markedly reduced in the CTX + MQ group compared with CTX alone (0/105 vs. 5/103, P = 0.03). Because of insufficient recruitment in the CTX-not-mandatory trial, noninferiority could not be conclusively assessed. Dizziness and vomiting of moderate intensity were reported by 34%-37% of women receiving MQ in both the trials, versus 0%-3% in CTX groups (P < 0.0001). No serious adverse events related to these drugs were found.

CONCLUSIONS: CTX alone provided adequate protection against malaria in HIV-infected pregnant women, although MQ-IPTp showed higher efficacy against placental infection. Although more frequently associated with dizziness and vomiting, MQ-IPTp may be an effective alternative given concerns about parasite resistance to CTX.

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Cotrimoxazole Prophylaxis Versus Mefloquine Intermittent Preventive Treatment to Prevent Malaria in HIV-Infected Pregnant Women

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