Prevention of Pregnancy-associated Malaria in HIV-infected Women: Cotrimoxazole Prophylaxis Versus Mefloquine

NCT00970879 | Completed Phase 3 DMC

• 1 other identifier: IRD-Sidaction-01
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Malaria in Pregnancy; HIV Infections

Keywords

malaria; pregnancy; HIV; prevention; cotrimoxazole; mefloquine

Outcome Measures

Primary Outcomes (1)

• proportion of placental malaria (presence of parasites in the placental blood smear at delivery)

  delivery

Secondary Outcomes (10)

• placental malaria mean parasite density at delivery

  delivery

• proportion of low birth weight infants (<2500 g) and mean birth weight

  delivery

• proportion of maternal anaemia (<11g/dl) and severe maternal anaemia (<8g/dl) at delivery and during pregnancy

  course of pregnancy and delivery

• cord blood malaria infection at delivery (infant parasitemia)

  delivery

• pre-term deliveries (< 37 weeks)

  delivery

Study Arms (4)

cotrimoxazole (high)

EXPERIMENTAL

CD4 cell count≥350/mm3

Drug: cotrimoxazole

mefloquine

ACTIVE COMPARATOR

CD4 cell count≥350/mm3

Drug: mefloquine

cotrimoxazole (low)

EXPERIMENTAL

CD4 cell count\<350/mm3

Drug: cotrimoxazole

mefloquine & cotrimoxazole

ACTIVE COMPARATOR

CD4 cell count\<350/mm3

Drug: cotrimoxazole; Drug: mefloquine

Interventions

cotrimoxazole DRUG

800 mg sulfamethoxazole and 160 mg trimethoprim daily, from 28 weeks of gestation until delivery

cotrimoxazole (high); cotrimoxazole (low); mefloquine & cotrimoxazole

mefloquine DRUG

mefloquine 15 mg/Kg three times, between 16 and 28 weeks, 24 and 32 weeks, then 28 and 36 weeks of pregnancy

mefloquine; mefloquine & cotrimoxazole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed HIV seropositivity
• Permanent residency in the study catchment's area
• Confirmed pregnancy, gestational age\< 28 weeks
• More than 18 years of age
• Karnofsky index ≥80
• Willingness to deliver at the hospital
• Written informed consent

You may not qualify if:

• History of allergy to study drugs : sulpha drugs, mefloquine, quinine
• History or presence of major illnesses : severe renal disease , severe hepatic disease, severe neuropsychiatric disease
• Mefloquine or halofantrine received within the 4 weeks prior to enrolment

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Sidaction: collaborator
• Saint Antoine University Hospital: collaborator
• National University Hospital, Cotonou: collaborator
• Université d'Abomey-Calavi: collaborator
• Ministry of Health, Benin: collaborator

Study Sites (5)

Hôpital d'Instruction des Armées Camp Guézo

Cotonou, Benin

Location

Hôpital de la Mère et de l'Enfant Lagune

Cotonou, Benin

Location

Hôpital de zone de Suru Lere

Cotonou, Benin

Location

Unviversity Hospital Hubert Koutoukou Maga

Cotonou, Benin

Location

Clinique Louis Pasteur

Porto-Novo, Benin

Location

Related Publications (2)

• Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

  PMID: 39324693 DERIVED

• Duvignaud A, Denoeud-Ndam L, Akakpo J, Agossou KV, Afangnihoun A, Komongui DG, Atadokpede F, Dossou-Gbete L, Girard PM, Zannou DM, Cot M. Incidence of malaria-related fever and morbidity due to Plasmodium falciparum among HIV1-infected pregnant women: a prospective cohort study in South Benin. Malar J. 2014 Jul 4;13:255. doi: 10.1186/1475-2875-13-255.

  PMID: 24996807 DERIVED

MeSH Terms

Conditions

HIV Infections; Malaria

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Mefloquine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marcel D Zannou, Professor

  Cotonou University Hospital & Faculté des Sciences de la Santé, Benin

  PRINCIPAL INVESTIGATOR

• Pierre-Marie Girard, Professor

  Saint Antoine Hospital, Assistance Publique-Hôpitaux se Paris

  STUDY CHAIR

• Michel Cot, MD, PHD

  Institut de Recherche pour le Developpement

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: September 2, 2009
• First Posted: September 3, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

BE (5)