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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03671109




Registration number
NCT03671109
Ethics application status
Date submitted
6/09/2018
Date registered
14/09/2018

Titles & IDs
Public title
Improving Maternal heAlth by Reducing Malaria in African HIV Women
Scientific title
Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women
Secondary ID [1] 0 0
EDCTP- RIA2016MC-1613
Universal Trial Number (UTN)
Trial acronym
MAMAH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 0 0
HIV/AIDS 0 0
Pregnancy Related 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dihydroartemisinin-piperaquine (DHA-PPQ)
Treatment: Drugs - Placebo Oral Tablet

Experimental: IPTp-DHA-PPQ - Monthly IPTp-DHA-PPQ over three days plus daily ARVs and cotrimoxazole prophylaxis

Placebo comparator: IPTp-Placebo - Monthly IPTp-placebo over three days plus daily ARVs and cotrimoxazole prophylaxis


Treatment: Drugs: Dihydroartemisinin-piperaquine (DHA-PPQ)
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-DHA-PPQ under supervision

Treatment: Drugs: Placebo Oral Tablet
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-Placebo under supervision
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maternal parasitaemia at delivery
Timepoint [1] 0 0
Delivery
Secondary outcome [1] 0 0
Incidence of clinical malaria
Timepoint [1] 0 0
On average six months follow up during pregnancy
Secondary outcome [2] 0 0
Incidence of all-cause admissions
Timepoint [2] 0 0
On average six months follow up during pregnancy
Secondary outcome [3] 0 0
Incidence of all-cause outpatient attendances
Timepoint [3] 0 0
On average six months follow up during pregnancy
Secondary outcome [4] 0 0
Frequency and severity of adverse events
Timepoint [4] 0 0
On average six months follow up during pregnancy
Secondary outcome [5] 0 0
Mean haemoglobin concentration
Timepoint [5] 0 0
At delivery
Secondary outcome [6] 0 0
Prevalence of submicroscopic P. falciparum peripheral parasitaemia
Timepoint [6] 0 0
At delivery
Secondary outcome [7] 0 0
Prevalence of anaemia (Hb<11 g/dL)
Timepoint [7] 0 0
At delivery
Secondary outcome [8] 0 0
Prevalence of severe anaemia (Hb<7 g/dL)
Timepoint [8] 0 0
At delivery
Secondary outcome [9] 0 0
Mean CD4+ T cell counts levels
Timepoint [9] 0 0
At delivery
Secondary outcome [10] 0 0
Proportion of women with detectable HIV viral load
Timepoint [10] 0 0
At delivery
Secondary outcome [11] 0 0
Prevalence of placental P. falciparum infection
Timepoint [11] 0 0
At delivery
Secondary outcome [12] 0 0
Prevalence of P. falciparum peripheral parasitaemia at the post-partum visit
Timepoint [12] 0 0
On average 42 days after end of pregnancy (post-partum visit)
Secondary outcome [13] 0 0
Maternal mortality rate
Timepoint [13] 0 0
On average six months follow up during pregnancy and 42 days after end of pregnancy (post-partum visit)
Secondary outcome [14] 0 0
Prevalence of P. falciparum parasitaemia in cord blood
Timepoint [14] 0 0
At birth
Secondary outcome [15] 0 0
Prevalence of neonatal anaemia
Timepoint [15] 0 0
Neonatal period ( in first 28 days of life)
Secondary outcome [16] 0 0
Mean birth weight
Timepoint [16] 0 0
At birth
Secondary outcome [17] 0 0
Prevalence of low birth weight (<2500 g)
Timepoint [17] 0 0
At birth
Secondary outcome [18] 0 0
Mean gestational age at birth
Timepoint [18] 0 0
At birth
Secondary outcome [19] 0 0
Prevalence of prematurity
Timepoint [19] 0 0
At birth
Secondary outcome [20] 0 0
Prevalence of embryo and foetal losses
Timepoint [20] 0 0
On average six months follow up during pregnancy
Secondary outcome [21] 0 0
Prevalence of small for gestational age
Timepoint [21] 0 0
At birth
Secondary outcome [22] 0 0
Frequency of congenital malformations
Timepoint [22] 0 0
At birth
Secondary outcome [23] 0 0
Incidence of clinical malaria
Timepoint [23] 0 0
During first year of life
Secondary outcome [24] 0 0
Neonatal mortality rate
Timepoint [24] 0 0
During neonatal period (during first 28 days of life)
Secondary outcome [25] 0 0
Frequency of mother to child transmission of HIV at one and at 12 months of age
Timepoint [25] 0 0
During first year of life
Secondary outcome [26] 0 0
Infant mortality rate
Timepoint [26] 0 0
During first year of life
Secondary outcome [27] 0 0
Composite malaria outcome: proportion of participants with malaria infection diagnosed
Timepoint [27] 0 0
From enrolment until one month after end of pregnancy (on average seven months of study follow up of women, depending on gestational age at inclusion)
Secondary outcome [28] 0 0
Composite maternal malaria and anemia: proportion of particiapnts diganosed either with malaria or anemia
Timepoint [28] 0 0
At delivery
Secondary outcome [29] 0 0
Composite adverse pregnancy outcome
Timepoint [29] 0 0
Birth

Eligibility
Key inclusion criteria
* 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
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/06/2023
Sample size
Target
Accrual to date
Final
666
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Gabon
State/province [1] 0 0
Lambaréné
Country [2] 0 0
Mozambique
State/province [2] 0 0
Manhiça

Funding & Sponsors
Primary sponsor type
Other
Name
Barcelona Institute for Global Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medicines for Malaria Venture
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Universität Tübingen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Centre de Recherche Médicale de Lambaréné
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Medical University of Vienna
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Bernhard Nocht Institute for Tropical Medicine
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Centro de Investigação em Saúde de Manhiça
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clara Menendez, MD, PhD
Address 0 0
Barcelona Institute for Global Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
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.
Available to whom?
Open Access
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT03671109