Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2010020001813440 Date of Approval: 01/02/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY IN HIV+ PATIENTS
Official scientific title EVALUATION OF THE SAFETY AND EFFICACY OF MEFLOQUINE AS INTERMITTENT PREVENTIVE TREATMENT FOR MALARIA IN PREGNANCY IN HIV+ PATIENTS
Brief summary describing the background and objectives of the trial 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. The evaluation of alternative antimalarials for IPTp is thus urgently needed.This study aims to compare the efficacy of MQ as IPTp with placebo-IPTp in HIV-infected pregnannt women receiving CTX prophylaxis.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) MIPPAD HIV
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Malaria
Purpose of the trial Prevention
Anticipated trial start date 15/02/2010
Actual trial start date
Anticipated date of last follow up 16/02/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
EDCTP IP.07.31080.002 EDCTP
EDCTP IP.07.31080.002 EDCTP
NCT00811421 Clinicaltrials.gov
NCT00811421 Clinicaltrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Drug administration: Mefloquine (full dose) MQ oral administration (15 mg/Kg) at the 1st and 2nd Antenatal Clinic visit as IPTp pregnancy 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) 535
Control Group Drug administration: MQ-Placebo MQ-Placebo oral administration at the 1st and 2nd Antenatal Clinic visit as IPTp pregnancy Trial 2: CTX + IPTp-Placebo+ LLITNs: Experimental HIV-positive pregnant women receiving 3 doses of IPTp (placebo) in the context of long lasting Insecticide Treated Nets (LLITNs) 535 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Trial 2: Permanent resident in the area. Gestational age at the first antenatal visit < 28 weeks HIV seropositive (after voluntary counseling and testing) Indication to receive CTX prophylaxis (according to the national guidelines) Signed informed consent Agreement to deliver in the study site's maternity wards Trial 2: Residence outside the study area or planning to move out in the following 10 months from enrollment Gestational age at the first antenatal visit > 28 weeks of pregnancy Known history of allergy to CTX or MQ Known history of severe renal, hepatic, psychiatric or neurological disease MQ or halofantrine treatment in the preceding 4 weeks 15 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/10/2009 CE
Ethics Committee Address
Street address City Postal code Country
Cotonou Benin
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/01/2008 CEIC
Ethics Committee Address
Street address City Postal code Country
Barcelona Spain
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2008 CERIL
Ethics Committee Address
Street address City Postal code Country
Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2008 CNBS
Ethics Committee Address
Street address City Postal code Country
Av. Eduardo Mondlame/Salvador Allende Maputo 264 Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/12/2008 IRB
Ethics Committee Address
Street address City Postal code Country
Dar es Salaam Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/01/2009 NERB
Ethics Committee Address
Street address City Postal code Country
Nairobi Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Maternal anemia at delivery Delivery
Secondary Outcome Perinatal mortality Pregnancy
Secondary Outcome Neonatal mortality Delivery
Secondary Outcome Number of stillbirths Pregnancy
Secondary Outcome Incidence of clinical malaria during pregnancy Pregnancy
Secondary Outcome Mean maternal hemoglobin rate g/dL Enrolment, Delivery, 1 month postdelivery
Secondary Outcome Prevalence of P.falciparum parasitemia in cord blood Delivery
Secondary Outcome Incidence of overall admissions/outpatient attendances Pregnancy
Secondary Outcome Prevalence of congenital malaria Delivery
Secondary Outcome Mean birth weight Delivery
Secondary Outcome Frequency of drug adverse reactions Pregnancy
Secondary Outcome Frequency of congenital malformations delivery
Secondary Outcome Prevalence of placental P.Falciparum infection Delivery
Primary Outcome Peripheral parasitemia at delivery Delivery
Secondary Outcome Prevalence low birth weight babies Delivery
Secondary Outcome Prevalence of fetal anemia Delivery
Secondary Outcome Prevalence of preterm babies Delivery
Secondary Outcome Mean of CD4 count and viral load Delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ifakara Health Institute Dar es Salaam Tanzania
Centro de Investigaçao em Saude de Manhiça Manhiça 1929 Mozambique
Medical Research Unit, Albert Schweizer Hospital Lambarene Gabon
Faculté des Sciencies de la Sante Cotonou Benin
Kenya medical research institute Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Malaria in Pregnancy Consortium
Malaria in Pregnancy Consortium
EDCTP
EDCTP
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FCRB Barcelona Spain Charities/Societies/Foundation
Primary Sponsor FCRB Barcelona Spain Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Achille Massougbodgi Cotonou Benin
Achille Massougbodgi Cotonou Benin
Gabriela Schreyer Vienna Austria
Gabriela Schreyer Vienna Austria
Michel Cot Paris France
Michel Cot Paris France
Michael Ramharter Tuebingen Germany
Michael Ramharter Tuebingen Germany
Ghyslain Mombo-Ngoma Lambarene Gabon
Ghyslain Mombo-Ngoma Lambarene Gabon
Meghna Desai Kisumu Kenya
Meghna Desai Kisumu Kenya
Salim Abdulla Ifakara Tanzania
Salim Abdulla Ifakara Tanzania
Eusebio Macete Manhiça Mozambique
Eusebio Macete Manhiça Mozambique
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clara Menendez menendez@clinic.ub.es +34 93 227 18 51 Rossello 132, 5-1
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Head of Maternal Health Department
Role Name Email Phone Street address
Public Enquiries Golbahar Pahlavan golbahar.pahlavan@cresib.cat +34 93 227 18 51 Rossello 132, 5-1
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Project Manager
Role Name Email Phone Street address
Scientific Enquiries Raquel Gonzalez Raquel.Gonzalez@cresib.cat +34 93 227 18 51 Rossello 132, 5-1
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Epidemiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information