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Efficacy of Antifolates Against Malaria in HIV-infected Pregnant Women and the Emergence of Induced Resistance in Plasmodium Falciparum

NCT01746199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2020-11-30

No results posted yet for this study

Summary

Given the resistance emergence of malaria in pregnant women receiving intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among pregnant women infected by HIV it is urgent to seek a more effective alternative treatment to optimize the prevention of malaria. Cotrimoxazole (CTM), actually administered daily as a prophylactic mean to opportunistic infections for HIV infected patients, showed encouraging results in preventing malaria in pregnant women. However, these results must be confirmed by randomized trials, particularly in pregnant women.

The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM), administered once daily with IPT-SP (3 curative doses spaced one month) on placental parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) \> 350 cells/mm3.

The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP for placental parasitaemia. This might be due to the higher plasma concentration of cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could be recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell count. In this study, the investigators will also test the hypothesis that the strains of Plasmodium falciparum isolated from HIV-positive pregnant women express more dhfr and dhps resistance markers.

Conditions

  • Malaria in Pregnancy
  • HIV Infection

Interventions

DRUG

cotrimoxazole daily prophylaxis

DRUG

sulphadoxine-pyrimethamine

Intermittent preventive sulphadoxine-pyrimethamine treatment

Sponsors & Collaborators

  • Institut Pasteur de Bangui

    collaborator AMBIG

  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Muriel Vray · Unité d'épidémiologie des maladies émergentes, Institut Pasteur Paris, France

  • Alexandre Manirakiza, MD · Unité d'Epidémiologie, Institut Pasteur de Bangui, Central African Republic

  • Mirdad Kazanji · Director of the Institut Pasteur de Bangui, Central African Republic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-10-31
Completion
2019-12-31

Countries

  • Central African Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01746199 on ClinicalTrials.gov