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| Sponsors and Collaborators: |
Hospital Clinic of Barcelona Centre de Recerca en Salut Internacional de Barcelona (CRESIB). Spain Institute of Tropical Medicine, University of Tübingen, Germany Institut de Recherche pour le Développement (IRD), France Faculté des Sciences de la Santé (FSS), Université d'Abomey Calavi, Cotonou, Benin Medical Research Unit (MRU), Albert Schweitzer Hospital. Lambaréné, Gabon Kenya Medical Research Institute Ifakara Health Institute (IHI). Ifakara, Tanzania Centro de Investigaçao em Saúde da Manhiça (CISM). Manhiça, Mozambique. Vienna School of Clinical Research (VSCR), Austria. US Centers for Disease Control and Prevention Malaria in Pregnancy (MiP) Consortium |
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| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00811421 |
Purpose
The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy Malaria Prevention HIV Infections |
Drug: Sulphadoxine-pyrimethamine Drug: Mefloquine Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Evaluation of the Safety and Efficacy of Mefloquine as Intermittent Preventive Treatment of Malaria in Pregnancy |
| Estimated Enrollment: | 5330 |
| Arms | Assigned Interventions |
|---|---|
|
Trial 1: IPTp-SP+LLITNs: Active Comparator
HIV-negative pregnant women receiving 2 doses of IPTp (500mg of sulfadoxine and 25 mg of pyrimethamine) in the context of long lasting Insecticide Treated Nets (LLITNs)
|
Drug: Sulphadoxine-pyrimethamine
SP oral administration (500mg sulphadoxine and 25mg pyrimethamine) as IPTp at the 1st and 2nd Antenatal Clinic visit
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Trial 1: IPTp-MQ+ LLITNs: Experimental
HIV-negative pregnant women receiving 2 doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs)
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Drug: Mefloquine
MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp
|
|
Trial 2: CTX+IPTp-Placebo+LLITNs: Placebo Comparator
HIV-positive pregnant women receiving 3 doses of IPTp (placebo) in the context of long lasting Insecticide Treated Nets (LLITNs)
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Drug: Placebo
MQ-placebo oral administration at the 1st, 2nd and 3rd Antenatal Clinic visit as IPTp
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Trial 2: CTX + IPTp-MQ+ LLITNs: Experimental
HIV-positive pregnant women receiving 3 doses of IPTp (15 mg/Kg) in the context of long lasting Insecticide Treated Nets (LLITNs)
|
Drug: Mefloquine
MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp
|
The current recommendation by the World Health Organization (WHO) to prevent malaria infection in pregnancy in areas of stable malaria transmission relies on:
However, the spread of parasite resistance to SP, particularly in eastern Africa, and the significant overlap in some regions of malaria transmission and high prevalence of HIV infection, have raised concerns about the medium and long-term use of SP for IPTp.
HIV infection increases susceptibility to malaria and may reduce the efficacy of interventions. The evaluation of alternative antimalarials for IPTp is thus urgently needed also involving HIV infected women.
Of all the current available alternative antimalarial drugs, mefloquine (MQ) is the one that offers the most comparative advantages to SP.
The protocol includes two trials:
Trial 1. Randomized open-label trial comparing the safety and efficacy of SP versus MQ as IPTp in the context of ITNs (n= 4260). Five African countries participate in this trial: Benin, Gabon, Kenya, Mozambique and Tanzania.
Trial 2. Randomized double-blinded trial comparing MQ-IPTp to placebo IPTp in HIV pregnant women receiving Cotrimoxazole prophylaxis and in the context of ITNs (n= 1070). Three African counties participate in this trial: Kenya, Mozambique and Tanzania.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Trial 1:
Trial 2:
Exclusion Criteria:
Trial 1:
Trial 2:
Contacts and Locations| Contact: Clara Menendez, MD, PhD | 34 93 2275400 | Menendez@clinic.ub.es |
| Contact: Raquel González, MD, MPH | 34 93 2275400 | ragonza@clinic.ub.es |
| Spain | |
| Centre Recerca en Salut Internacional de Barcelona (CRESIB) | |
| Barcelona, Spain, 08036 | |
| Principal Investigator: | Clara Menendez, MD, PhD | CRESIB |
More Information
| Responsible Party: | Fundacio Clinic per la Recerca Biomedica (FCRB) Spain ( Professor Clara Menendez Santos ) |
| Study ID Numbers: | IP.07.31080.002 |
| Study First Received: | December 18, 2008 |
| Last Updated: | February 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00811421 |
| Health Authority: | Spain: Ethics Committee; Benin: Ethics Committee; Gabon:Ethics Committee; United States: Institutional Review Board; Kenya: Ethical Review Committee; Tanzania:Ethics Committee; Mozambique: Ethics Committee |
|
Malaria Pregnancy HIV Prevention |
|
Pyrimethamine Protozoan Infections Sexually Transmitted Diseases, Viral Sulfadoxine-pyrimethamine Acquired Immunodeficiency Syndrome Malaria Sulfadoxine Immunologic Deficiency Syndromes |
Folic Acid Virus Diseases HIV Infections Sexually Transmitted Diseases Parasitic Diseases Mefloquine Retroviridae Infections |
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Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors |
Renal Agents Infection Folic Acid Antagonists Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Lentivirus Infections |
