MalariaPhase 3MAMAHNCT03671109
Improving Maternal heAlth by Reducing Malaria in African HIV Women
A Phase 3 study testing Dihydroartemisinin-piperaquine (DHA-PPQ) in people with Malaria and HIV/AIDS, run by Barcelona Institute for Global Health at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria, HIV/AIDS, Pregnancy Related
- What is being tested?
- Dihydroartemisinin-piperaquine (DHA-PPQ)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 666 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Sep 2019to 19 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women
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.
Read the detailed description
Background
Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-uninfected women but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects. A recent trial showed that an effective antimalarial added to CTXp and long-lasting insecticide treated nets (LLITNs) in HIV-infected pregnant women improves malaria prevention and maternal health. However, the antimalarial used -mefloquine- was not well tolerated and it was associated with an increase in HIV viral load at delivery and a two-fold increased risk of MTCT-HIV. These findings highlight the need to find alternative drugs with better tolerability and safety profile to prevent malaria in this vulnerable group and to further study the pharmacological interactions between antimalarials and antiretrovirals (ARVs).
Dihydroartemisinin-piperaquine (DHA-PPQ), because of its long half-life and good tolerability has been shown to improve antimalarial protection in HIV-uninfected pregnant women, constituting the most promising candidate for IPTp in HIV-infected pregnant women. However, there is limited information on the pharmacokinetics of DHA-PPQ with concomitant use of ARV drugs and CTX, particularly in pregnant women.
Objectives
- To evaluate the safety, tolerability and efficacy of DHA-PPQ as IPTp for malaria prevention in HIV-infected pregnant women receiving daily CTXp and ARV drugs
- To assess the effect of DHA-PPQ as IPTp on mother to child transmission of HIV
- To study the effects of DHA-PPQ on the pharmacokinetics of clinically relevant doses of ARV drugs used for prevention of MTCT and treatment of HIV infection
- To evaluate the effectiveness of CTXp in clearing malaria parasites in HIV-infected pregnant women
Methods
The trial has been designed as a randomized double blind placebo-controlled superiority trial to evaluate the safety and efficacy of DHA-PPQ as IPTp in HIV-infected pregnant women taking daily CTXp and ARV drugs. The trial sites are located in Central and South Eastern sub-Saharan Africa (Gabon and Mozambique), where HIV prevalence among pregnant women ranges from 6 to 29%.
Based on previous estimations at the study sites and assuming a prevalence of peripheral parasitaemia at delivery of 7.5% with CTXp, it is estimated that 298 women per arm will be required to detect with 80% power a significant (p<0.05) decrease of 5% or more in the prevalence of peripheral parasitaemia in the CTXp+IPTp-DHA-PPQ group. In order to allow for 10% losses to follow up, it is calculated that 332 women/study arm will need to be recruited (total n=664). Furthermore, assuming a 5% MTCT-HIV in the control group, this sample size will have an 80% power to detect at the 5% level of significance, 2.2 times difference in the risk of MTCT-HIV.
The trial will have two study arms; HIV-infected pregnant women participating in the trial will be randomized to receive either:
- Monthly doses of IPTp-DHA-PPQ over three days plus daily ARVs and cotrimoxazole prophylaxis
- Monthly doses of IPTp-placebo over three days plus daily ARVs and cotrimoxazole prophylaxis
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.
Participants will be asked to visit the ANC monthly and to deliver at the study health facilities. Adherence to CTX prophylaxis and ARV therapy, as well as use of the LLITNs use will be assessed monthly at the scheduled antenatal care (ANC) clinic visits.
Pharmacokinetic (PK) sub-study The possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants (n=200).
- Conditions
- Malaria, HIV/AIDS, Pregnancy Related
- Being tested
- Dihydroartemisinin-piperaquine (DHA-PPQ), Placebo Oral Tablet
- Keywords
- Malaria, Dihydroartemisinin-piperaquine, HIV, Pregnancy, Treatment, Prevention
- Medical subject headings
- Malaria, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-piperaquine (DHA-PPQ)Drug
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-DHA-PPQ under supervision
Placebo Oral TabletDrug
Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-Placebo under supervision
| Study group | Role | What they receive |
|---|---|---|
| IPTp-DHA-PPQ | Experimental | Monthly IPTp-DHA-PPQ over three days plus daily ARVs and cotrimoxazole prophylaxis Receives: Drug: Dihydroartemisinin-piperaquine (DHA-PPQ) |
| IPTp-Placebo | Placebo comparator | Monthly IPTp-placebo over three days plus daily ARVs and cotrimoxazole prophylaxis Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal parasitaemia at delivery
Presence of Plasmodium falciparum (P. falciparum) asexual parasites of any density in peripheral blood (determined by microscopy)
Measured: Delivery
Secondary outcomes (29)
Incidence of clinical malaria
Measured: On average six months follow up during pregnancy
Incidence of all-cause admissions
Measured: On average six months follow up during pregnancy
Incidence of all-cause outpatient attendances
Measured: On average six months follow up during pregnancy
Frequency and severity of adverse events
Measured: On average six months follow up during pregnancy
Mean haemoglobin concentration
Measured: At delivery
Prevalence of submicroscopic P. falciparum peripheral parasitaemia
Measured: At delivery
Prevalence of anaemia (Hb<11 g/dL)
Measured: At delivery
Prevalence of severe anaemia (Hb<7 g/dL)
Measured: At delivery
Mean CD4+ T cell counts levels
Measured: At delivery
Proportion of women with detectable HIV viral load
Measured: At delivery
Prevalence of placental P. falciparum infection
Measured: At delivery
Prevalence of P. falciparum peripheral parasitaemia at the post-partum visit
Measured: On average 42 days after end of pregnancy (post-partum visit)
Maternal mortality rate
Measured: On average six months follow up during pregnancy and 42 days after end of pregnancy (post-partum visit)
Prevalence of P. falciparum parasitaemia in cord blood
Measured: At birth
Prevalence of neonatal anaemia
Measured: Neonatal period ( in first 28 days of life)
Mean birth weight
Measured: At birth
Prevalence of low birth weight (<2500 g)
Measured: At birth
Mean gestational age at birth
Measured: At birth
Prevalence of prematurity
Measured: At birth
Prevalence of embryo and foetal losses
Measured: On average six months follow up during pregnancy
Prevalence of small for gestational age
Measured: At birth
Frequency of congenital malformations
Measured: At birth
Incidence of clinical malaria
Measured: During first year of life
Neonatal mortality rate
Measured: During neonatal period (during first 28 days of life)
Frequency of mother to child transmission of HIV at one and at 12 months of age
Measured: During first year of life
Infant mortality rate
Measured: During first year of life
Composite malaria outcome: proportion of participants with malaria infection diagnosed
Any malaria confirmed infection during follow up, delivery and post-partum period (blood smear, malaria PCR, placental infection)
Measured: 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)
Composite maternal malaria and anemia: proportion of particiapnts diganosed either with malaria or anemia
Measured: At delivery
Composite adverse pregnancy outcome
LBW, miscarriage, stillbirth, prematurity
Measured: Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start18 Sep 2019
- Primary completion19 Jul 2022
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Superiority clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medicines for Malaria Venture, Universität Tübingen, Centre de Recherche Médicale de Lambaréné, Medical University of Vienna, Bernhard Nocht Institute for Tropical Medicine, Centro de Investigação em Saúde de Manhiça
- Responsible party
- Sponsor
- Investigators
- Clara Menendez, MD, PhD, Study director, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671109
- Sponsor's protocol ID
- EDCTP- RIA2016MC-1613
- Acronym
- MAMAH
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2018
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38224706Gonzalez 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.
PubMed 34815285Stoger L, Mischlinger J, Nhampossa T, Mombo-Ngoma G, Esen M, Tchouatieu A-M, Brunet M, Mendes A, Dimessa Mbadinga LB, Gamberini S, Ndzebe Ndoumba W, Figueroa-Romero A, Lell B, Lagler H, Zoleko-Manego R, El Gaaloul M, Mendez S, Botella N, Sanz S, Piqueras M, Sevene E, Saute F, Wicha SG, Soy D, Menendez C, Ramharter M, Gonzalez R; MAMAH Study Group. Effects of malaria intermittent preventive treatment with dihydroartemisinin-piperaquine on antiretroviral drug concentrations in African pregnant women living with HIV. Antimicrob Agents Chemother. 2026 Jul;70(7):e0033726. doi: 10.1128/aac.00337-26. Epub 2026 Jun 12.
PubMed 42283563Pons-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.
PubMed 39324693
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women
- ClinicalTrials.gov ID
- NCT03671109
- Acronym / sponsor ID
- MAMAH / EDCTP- RIA2016MC-1613
- Conditions
- Malaria, HIV/AIDS, Pregnancy Related
- Keywords
- Malaria, Dihydroartemisinin-piperaquine, HIV, Pregnancy, Treatment, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- Medicines for Malaria Venture, Universität Tübingen, Centre de Recherche Médicale de Lambaréné, Medical University of Vienna, Bernhard Nocht Institute for Tropical Medicine, Centro de Investigação em Saúde de Manhiça
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-uninfected women but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects. A recent trial showed that an effective antimalarial added to CTXp and long-lasting insecticide treated nets (LLITNs) in HIV-infected pregnant women improves malaria prevention and maternal health. However, the antimalarial used -mefloquine- was not well tolerated and it was associated with an increase in HIV viral load at delivery and a two-fold increased risk of MTCT-HIV. These findings highlight the need to find alternative drugs with better tolerability and safety profile to prevent malaria in this vulnerable group and to further study the pharmacological interactions between antimalarials and antiretrovirals (ARVs).
Dihydroartemisinin-piperaquine (DHA-PPQ), because of its long half-life and good tolerability has been shown to improve antimalarial protection in HIV-uninfected pregnant women, constituting the most promising candidate for IPTp in HIV-infected pregnant women. However, there is limited information on the pharmacokinetics of DHA-PPQ with concomitant use of ARV drugs and CTX, particularly in pregnant women.
Objectives
- To evaluate the safety, tolerability and efficacy of DHA-PPQ as IPTp for malaria prevention in HIV-infected pregnant women receiving daily CTXp and ARV drugs
- To assess the effect of DHA-PPQ as IPTp on mother to child transmission of HIV
- To study the effects of DHA-PPQ on the pharmacokinetics of clinically relevant doses of ARV drugs used for prevention of MTCT and treatment of HIV infection
- To evaluate the effectiveness of CTXp in clearing malaria parasites in HIV-infected pregnant women
Methods
The trial has been designed as a randomized double blind placebo-controlled superiority trial to evaluate the safety and efficacy of DHA-PPQ as IPTp in HIV-infected pregnant women taking daily CTXp and ARV drugs. The trial sites are located in Central and South Eastern sub-Saharan Africa (Gabon and Mozambique), where HIV prevalence among pregnant women ranges from 6 to 29%.
Based on previous estimations at the study sites and assuming a prevalence of peripheral parasitaemia at delivery of 7.5% with CTXp, it is estimated that 298 women per arm will be required to detect with 80% power a significant (p<0.05) decrease of 5% or more in the prevalence of peripheral parasitaemia in the CTXp+IPTp-DHA-PPQ group. In order to allow for 10% losses to follow up, it is calculated that 332 women/study arm will need to be recruited (total n=664). Furthermore, assuming a 5% MTCT-HIV in the control group, this sample size will have an 80% power to detect at the 5% level of significance, 2.2 times difference in the risk of MTCT-HIV.
The trial will have two study arms; HIV-infected pregnant women participating in the trial will be randomized to receive either:
- Monthly doses of IPTp-DHA-PPQ over three days plus daily ARVs and cotrimoxazole prophylaxis
- Monthly doses of IPTp-placebo over three days plus daily ARVs and cotrimoxazole prophylaxis
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.
Participants will be asked to visit the ANC monthly and to deliver at the study health facilities. Adherence to CTX prophylaxis and ARV therapy, as well as use of the LLITNs use will be assessed monthly at the scheduled antenatal care (ANC) clinic visits.
Pharmacokinetic (PK) sub-study The possibility for a PK interaction between DHA-PPQ and ARV drugs will be assessed in a sub-sample of participants (n=200).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Superiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| IPTp-DHA-PPQ | Experimental | Drug: Dihydroartemisinin-piperaquine (DHA-PPQ)Monthly IPTp-DHA-PPQ over three days plus daily ARVs and cotrimoxazole prophylaxis |
| IPTp-Placebo | Placebo comparator | Drug: Placebo Oral TabletMonthly IPTp-placebo over three days plus daily ARVs and cotrimoxazole prophylaxis |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dihydroartemisinin-piperaquine (DHA-PPQ)Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-DHA-PPQ under supervision | Drug | IPTp-DHA-PPQ |
| Placebo Oral TabletFollowing physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-Placebo under supervision | Drug | IPTp-Placebo |
Primary outcome
Maternal parasitaemia at delivery
Time frame: Delivery
Presence of Plasmodium falciparum (P. falciparum) asexual parasites of any density in peripheral blood (determined by microscopy)
29 secondary outcomes
Incidence of clinical malaria
Time frame: On average six months follow up during pregnancy
Incidence of all-cause admissions
Time frame: On average six months follow up during pregnancy
Incidence of all-cause outpatient attendances
Time frame: On average six months follow up during pregnancy
Frequency and severity of adverse events
Time frame: On average six months follow up during pregnancy
Mean haemoglobin concentration
Time frame: At delivery
Prevalence of submicroscopic P. falciparum peripheral parasitaemia
Time frame: At delivery
Prevalence of anaemia (Hb<11 g/dL)
Time frame: At delivery
Prevalence of severe anaemia (Hb<7 g/dL)
Time frame: At delivery
Mean CD4+ T cell counts levels
Time frame: At delivery
Proportion of women with detectable HIV viral load
Time frame: At delivery
Prevalence of placental P. falciparum infection
Time frame: At delivery
Prevalence of P. falciparum peripheral parasitaemia at the post-partum visit
Time frame: On average 42 days after end of pregnancy (post-partum visit)
Maternal mortality rate
Time frame: On average six months follow up during pregnancy and 42 days after end of pregnancy (post-partum visit)
Prevalence of P. falciparum parasitaemia in cord blood
Time frame: At birth
Prevalence of neonatal anaemia
Time frame: Neonatal period ( in first 28 days of life)
Mean birth weight
Time frame: At birth
Prevalence of low birth weight (<2500 g)
Time frame: At birth
Mean gestational age at birth
Time frame: At birth
Prevalence of prematurity
Time frame: At birth
Prevalence of embryo and foetal losses
Time frame: On average six months follow up during pregnancy
Prevalence of small for gestational age
Time frame: At birth
Frequency of congenital malformations
Time frame: At birth
Incidence of clinical malaria
Time frame: During first year of life
Neonatal mortality rate
Time frame: During neonatal period (during first 28 days of life)
Frequency of mother to child transmission of HIV at one and at 12 months of age
Time frame: During first year of life
Infant mortality rate
Time frame: During first year of life
Composite malaria outcome: proportion of participants with malaria infection diagnosed
Time frame: 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)
Composite maternal malaria and anemia: proportion of particiapnts diganosed either with malaria or anemia
Time frame: At delivery
Composite adverse pregnancy outcome
Time frame: Birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Results publication: PubMed 38224706Gonzalez 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.
- Results publication: PubMed 34815285Gonzalez 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.
- Derived from this study: PubMed 42283563Stoger L, Mischlinger J, Nhampossa T, Mombo-Ngoma G, Esen M, Tchouatieu A-M, Brunet M, Mendes A, Dimessa Mbadinga LB, Gamberini S, Ndzebe Ndoumba W, Figueroa-Romero A, Lell B, Lagler H, Zoleko-Manego R, El Gaaloul M, Mendez S, Botella N, Sanz S, Piqueras M, Sevene E, Saute F, Wicha SG, Soy D, Menendez C, Ramharter M, Gonzalez R; MAMAH Study Group. Effects of malaria intermittent preventive treatment with dihydroartemisinin-piperaquine on antiretroviral drug concentrations in African pregnant women living with HIV. Antimicrob Agents Chemother. 2026 Jul;70(7):e0033726. doi: 10.1128/aac.00337-26. Epub 2026 Jun 12.
- Derived from this study: PubMed 39324693Pons-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.
- EDCTP web page with basic information on the projectLink provided by the sponsor.
- Project webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Menendez, MD, PhD study director
Barcelona Institute for Global Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dihydroartemisinin-piperaquine (DHA-PPQ) in people with Malaria and HIV/AIDS, run by Barcelona Institute for Global Health at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Gabon, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal parasitaemia at delivery (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03671109, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.