Improving Maternal heAlth by Reducing Malaria in African HIV Women
MAMAH
Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women
1 other identifier
interventional
666
2 countries
2
Brief Summary
Trial to evaluate the safety and efficacy of DHA-PPQ for Intermittent Preventive Treatment (IPTp) in HIV-infected pregnant women receiving cotrimoxazole prophylaxis (CTXp) and antiretroviral (ARV) drugs and using long lasting insecticide treated nets will be conducted in Mozambique and Gabon where malaria and HIV infection are moderate to highly prevalent. In addition, the possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants. Women will receive ARV therapy according to national guidelines and their infants will be followed until one year of age to evaluate the impact of DHA-PPQ on MTCT-HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2019
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedStudy Start
First participant enrolled
September 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2023
CompletedOctober 1, 2024
September 1, 2024
2.8 years
September 6, 2018
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maternal parasitaemia at delivery
Presence of Plasmodium falciparum (P. falciparum) asexual parasites of any density in peripheral blood (determined by microscopy)
Delivery
Secondary Outcomes (29)
Incidence of clinical malaria
On average six months follow up during pregnancy
Incidence of all-cause admissions
On average six months follow up during pregnancy
Incidence of all-cause outpatient attendances
On average six months follow up during pregnancy
Frequency and severity of adverse events
On average six months follow up during pregnancy
Mean haemoglobin concentration
At delivery
- +24 more secondary outcomes
Study Arms (2)
IPTp-DHA-PPQ
EXPERIMENTALMonthly IPTp-DHA-PPQ over three days plus daily ARVs and cotrimoxazole prophylaxis
IPTp-Placebo
PLACEBO COMPARATORMonthly IPTp-placebo over three days plus daily ARVs and cotrimoxazole prophylaxis
Interventions
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-DHA-PPQ under supervision
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-Placebo under supervision
Eligibility Criteria
You may qualify if:
- Permanent resident in the study area
- Gestational age at the first antenatal visit ≤ 28 weeks
- HIV seropositive status
- Agreement to deliver in the study site's maternity(ies) wards
You may not qualify if:
- Residence outside the study area or planning to move out in the following 10 months from enrolment
- Gestational age at the first antenatal visit \> 28 weeks of pregnancy
- Known history of allergy to CTX
- Known history of allergy or contraindications to DHA-PPQ
- Participating in other intervention studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barcelona Institute for Global Healthlead
- Medicines for Malaria Venturecollaborator
- Universität Tübingencollaborator
- Centre de Recherche Médicale de Lambarénécollaborator
- Medical University of Viennacollaborator
- Bernhard Nocht Institute for Tropical Medicinecollaborator
- Centro de Investigação em Saúde de Manhiçacollaborator
Study Sites (2)
Centre de Recherches Médicales de Lambaréné (CERMEL)
Lambaréné, Gabon
Centro de Investigação em Saúde de Manhiça (CISM)
Manhiça, Mozambique
Related Publications (3)
Gonzalez R, Nhampossa T, Mombo-Ngoma G, Mischlinger J, Esen M, Tchouatieu AM, Mendes A, Figueroa-Romero A, Zoleko-Manego R, Lell B, Lagler H, Stoeger L, Dimessa LB, El Gaaloul M, Sanz S, Mendez S, Piqueras M, Sevene E, Ramharter M, Saute F, Menendez C; MAMAH study group. Safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in pregnant women with HIV from Gabon and Mozambique: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2024 May;24(5):476-487. doi: 10.1016/S1473-3099(23)00738-7. Epub 2024 Jan 12.
PMID: 38224706RESULTGonzalez R, Nhampossa T, Mombo-Ngoma G, Mischlinger J, Esen M, Tchouatieu AM, Pons-Duran C, Dimessa LB, Lell B, Lagler H, Garcia-Otero L, Zoleko Manego R, El Gaaloul M, Sanz S, Piqueras M, Sevene E, Ramharter M, Saute F, Menendez C. Evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: protocol of a multicentre, two-arm, randomised, placebo-controlled, superiority clinical trial (MAMAH project). BMJ Open. 2021 Nov 23;11(11):e053197. doi: 10.1136/bmjopen-2021-053197.
PMID: 34815285RESULTPons-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: 39324693DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clara Menendez, MD, PhD
Barcelona Institute for Global Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind placebo-controlled
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2018
First Posted
September 14, 2018
Study Start
September 18, 2019
Primary Completion
July 19, 2022
Study Completion
June 19, 2023
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Project metadata will be made available in formal reports to key stakeholders as soon as possible and to the wider public within 12 months after the end of the project. The announcement of the availability of the project metadata will be posted in the project website.
- Access Criteria
- Open Access
The main findings of the clinical trial will be submitted for publication in a peer reviewed journal within 12 months of study completion through an open access mechanism, or otherwise made available publicly in compliance with H2020 open access requirements. Primary project raw data will be published in the project website. This approach is taken to protect in particular the interests of the endemic country researchers and institutions and in acknowledgment of the primary research oversight by endemic country ethics review boards. At no stage will data containing personal information of research participants be released.