Study Stopped
Extremely slow enrollment
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)
PAACT-PV
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
1 other identifier
interventional
16
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2011
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedApril 13, 2012
April 1, 2012
11 months
April 19, 2010
April 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
63-day PCR-adjusted parasitological cure of P. vivax
63 days
Study Arms (3)
Mefloquine- Artesunate
EXPERIMENTALMefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Artemether-Lumefantrine
EXPERIMENTALArtemether-Lumefantrine, Lumet, Cipla 4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
Chloroquine
ACTIVE COMPARATORChloroquine (Farmaguinhos, Brazil): Tablets containing 250 mg Chloroquine salt given as 4 tablets at once on the first day (or 10 mg/kg) followed by 3 tablets once daily for the next 2 days (or 7,5 mg/kg)
Interventions
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
Tablets containing 250 mg Chloroquine salt given as 4 tablets at once on the first day (or 10 mg/kg) followed by 3 tablets once daily for the next 2 days (or 7,5 mg/kg)
Eligibility Criteria
You may qualify if:
- 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 delivery
- Willing to deliver in health facility
You may not qualify if:
- 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, digoxin)
- 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 consciousness).
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Geral Maternidade de Cruzeiro do Sul
Cruzeiro do Sul, Acre, Brazil
Hospital Municipal Teonila Alves
Anajás, Pará, Brazil
Centro de Pesquisa em Patologias Tropicais
Porto Velho, Rondônia, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghna Desai, MPH PhD
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 20, 2010
Study Start
February 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
April 13, 2012
Record last verified: 2012-04