AzTrials
AzTrials

Malaria in PregnancyPhase 3PACOMENCT00970879

Prevention of Pregnancy-associated Malaria in HIV-infected Women: Cotrimoxazole Prophylaxis Versus Mefloquine

A Phase 3 study testing cotrimoxazole and mefloquine in people with Malaria in Pregnancy and HIV Infections, run by Institut de Recherche pour le Developpement at 5 sites in Benin.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of cotrimoxazole prophylaxis in prevention of malaria during pregnancy in HIV-infected women, compared to intermittent preventive treatment with mefloquine. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Malaria in Pregnancy, HIV Infections
What is being tested?
cotrimoxazole and mefloquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
5 sitesBenin
Study dates
Dec 2009to Dec 2012
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed HIV seropositivity
  • Permanent residency in the study catchment's area
  • Confirmed pregnancy, gestational age< 28 weeks
  • More than 18 years of age
  • Karnofsky index ≥80
  • Willingness to deliver at the hospital
  • Written informed consent

Who cannot join

  • History of allergy to study drugs : sulpha drugs, mefloquine, quinine
  • History or presence of major illnesses : severe renal disease , severe hepatic disease, severe neuropsychiatric disease
  • Mefloquine or halofantrine received within the 4 weeks prior to enrolment

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Benin5 sites

  • Hôpital d'Instruction des Armées Camp Guézo

    Cotonou

  • Hôpital de la Mère et de l'Enfant Lagune

    Cotonou

  • Hôpital de zone de Suru Lere

    Cotonou

  • Unviversity Hospital Hubert Koutoukou Maga

    Cotonou

  • Clinique Louis Pasteur

    Porto-Novo

Other trials in Benin

About this study

Official title: Prevention of Pregnancy-associated Malaria in HIV-infected Women : Randomised Controlled Trial Testing Cotrimoxazole Prophylaxis Versus Intermittent Preventive Treatment With Mefloquine

The purpose of this study is to evaluate the efficacy of cotrimoxazole prophylaxis in prevention of malaria during pregnancy in HIV-infected women, compared to intermittent preventive treatment with mefloquine.

Read the detailed description

Malaria infection during pregnancy can have adverse effects on both mother and fetus, including maternal anaemia and low birth weight which are responsible for mother and infant mortality. It is a particular problem for women in their first and second pregnancies and for women who are HIV-positive. Maternal HIV infection potentiates many of these adverse effects. In HIV-infected women, the World Health Organization (WHO) advocates the use of insecticide-treated bednets, and drugs : If the CD4 cell count is below 350/mm3 or the HIV disease is in WHO stage 2, 3 or 4, cotrimoxazole prophylaxis for the prevention of pneumocystosis and toxoplasmosis is indicated, that is assumed to also protect those women from malaria. Otherwise, they have to receive at least three doses of intermittent preventive treatment (IPT), most commonly with sulfadoxine-pyrimethamine (SP) given at the antenatal care visits. If IPT with SP has been a subject of many investigations, cotrimoxazole efficacy has never been assessed in prevention of malaria during pregnancy.

The investigators aim to evaluate the efficacy of cotrimoxazole prophylaxis in prevention of malaria during pregnancy in HIV-infected women. The investigators postulate that cotrimoxazole prophylaxis is not inferior to IPT in all women, unrelated to their CD4 cell count. In the control arm, the investigators will use mefloquine as IPT. The safety and efficacy of this drug have already been assessed in HIV-negative patients (NCT00274235).

A randomized controlled trial will be conducted in five hospitals in Benin. Pregnant women will be enrolled both in the Antenatal Care unit and in the Infectious Diseases unit of each setting. All women will receive insecticide-treated bednets at enrolment. Randomization will be stratified by hospital and CD4 cell count range. Women assigned to cotrimoxazole will receive cotrimoxazole prophylaxis daily during all the course of pregnancy. Women assigned to mefloquine IPT will receive mefloquine three times during pregnancy. Women randomised in this arm and having a low CD4 cell count or an advanced HIV disease will also receive cotrimoxazole prophylaxis in prevention of HIV/AIDS opportunistic infections. Drug efficacy will be judged on the prevalence of placental malaria at delivery.

This study will contribute to updating the recommendations concerning the prevention of malaria during pregnancy in HIV-infected women.

Being tested
cotrimoxazole, mefloquine
Keywords
malaria, pregnancy, HIV, prevention, cotrimoxazole, mefloquine
Medical subject headings
HIV Infections, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cotrimoxazoleDrug

    800 mg sulfamethoxazole and 160 mg trimethoprim daily, from 28 weeks of gestation until delivery

  • mefloquineDrug

    mefloquine 15 mg/Kg three times, between 16 and 28 weeks, 24 and 32 weeks, then 28 and 36 weeks of pregnancy

Study groups in NCT00970879
Study groupRoleWhat they receive
cotrimoxazole (high)ExperimentalCD4 cell count≥350/mm3
Receives: Drug: cotrimoxazole
mefloquineActive comparatorCD4 cell count≥350/mm3
Receives: Drug: mefloquine
cotrimoxazole (low)ExperimentalCD4 cell count<350/mm3
Receives: Drug: cotrimoxazole
mefloquine & cotrimoxazoleActive comparatorCD4 cell count<350/mm3
Receives: Drug: cotrimoxazole; Drug: mefloquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. proportion of placental malaria (presence of parasites in the placental blood smear at delivery)

    Measured: delivery

Secondary outcomes (10)

  1. placental malaria mean parasite density at delivery

    Measured: delivery

  2. proportion of low birth weight infants (<2500 g) and mean birth weight

    Measured: delivery

  3. proportion of maternal anaemia (<11g/dl) and severe maternal anaemia (<8g/dl) at delivery and during pregnancy

    Measured: course of pregnancy and delivery

  4. cord blood malaria infection at delivery (infant parasitemia)

    Measured: delivery

  5. pre-term deliveries (< 37 weeks)

    Measured: delivery

  6. spontaneous abortions (early:<28 weeks, late: ≥28 weeks) and still births

    Measured: course of pregnancy

  7. congenital anomalies

    Measured: first 6 months of life

  8. safety profile of the two treatments: proportion and detailed description of adverse effects in each treatment arm

    Measured: course of pregnancy (mother) anf first 6 months of life (infant)

  9. Mother-to-child HIV transmission rate in each treatment arm

    Measured: 2 months after breastfeeding cessation

  10. To document the effect of cotrimoxazole in reducing infections in HIV-infected women, we will measure the incidence of bacterial and parasitic infections (other than malaria) during pregnancy

    Measured: course of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionJul 2012
  4. Study completionDec 2012

Resources

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
Masking
None (open label)
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00970879
Sponsor's protocol ID
IRD-Sidaction-01
Acronym
PACOME
Status last verified
Jan 2013
First submitted
2 Sep 2009
Last updated
23 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Pons-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

  • Duvignaud A, Denoeud-Ndam L, Akakpo J, Agossou KV, Afangnihoun A, Komongui DG, Atadokpede F, Dossou-Gbete L, Girard PM, Zannou DM, Cot M. Incidence of malaria-related fever and morbidity due to Plasmodium falciparum among HIV1-infected pregnant women: a prospective cohort study in South Benin. Malar J. 2014 Jul 4;13:255. doi: 10.1186/1475-2875-13-255.

    PubMed 24996807

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cotrimoxazole and mefloquine in people with Malaria in Pregnancy and HIV Infections, run by Institut de Recherche pour le Developpement at 5 sites in Benin.

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 7 inclusion and 3 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Benin. 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. 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?

proportion of placental malaria (presence of parasites in the placental blood smear 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 NCT00970879, which also lists 2 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 23 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in