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Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)

Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plasmodium Vivax Malaria

Intervention: Mefloquine- Artesunate (Drug); Artemether-Lumefantrine (Drug); Chloroquine (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Centers for Disease Control and Prevention

Official(s) and/or principal investigator(s):
Meghna Desai, MPH PhD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention


The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent relapse. As primaquine can not be used in pregnant women, these women remain at risk of relapse. As there is increasing concern about chloroquine resistant P. vivax in this region, there is a need to identify alternative treatment options. The artemisinin combination therapies are recommended for use against P. falciparum infections in pregnant women after the 1st trimester; additional data are needed to support the use of these drugs against P. vivax.

Clinical Details

Official title: A Multi-center, Open-label, Randomized Trial of Chloroquine, Artemether-Lumefantrine, and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Vivax Malaria in Pregnant Women in Brazil

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 63-day PCR-adjusted parasitological cure of P. vivax


Minimum age: 15 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Gestational age >16 weeks (determined by LMP and fundal height)- if there is

discordance between the two, the more conservative estimate (i. e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus

- Normal fetal heart beat detected by Doppler

- Presence of asexual P. vivax parasitemia ≤ 50,000 parasites/microliter (thick smear)

- Willing to sign or thumb print informed consent

- Willing to return for scheduled follow up visits for treatment and observation until


- Willing to deliver in health facility

Exclusion Criteria:

- Pregnancy < 16 weeks

- Microscopically confirmed P. falciparum or mixed infection/ parasitemia (P. vivax and

another species of Plasmodium, i. e. P. vivax, P. ovale, or P. malariae)

- History of allergy or hypersensitivity to interventional drugs

- Exposure to antimalarial drugs and other drugs with antimalarial activity within the

past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including AL and MA)

- Patients taking drugs with possible interaction with study drugs (ie. warfarin,


- History or family history of epilepsy or psychiatric disorder

- Presence of signs and symptoms of severe malaria, severe illness, or danger signs

- Hemoglobin < 7 g/dl

- Inability to tolerate oral medication (repeated vomiting, impairment of


- History of chronic disease including diabetes, renal failure, hepatic failure, heart

disease requiring anti-arrhythmic drugs or warfarin, HIV/ AIDS, known hemoglobinopathy

- Participant's inability to return for follow up visits

- Age <15 years

Locations and Contacts

Hospital Geral Maternidade de Cruzeiro do Sul, Cruzeiro do Sul, Acre, Brazil

Hospital Municipal Teonila Alves, Anajas, Para, Brazil

Centro de Pesquisa em Patologias Tropicais, Porto Velho, Rondonia, Brazil

Additional Information

Starting date: February 2011
Last updated: April 12, 2012

Page last updated: August 23, 2015

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