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

NCT ID: NCT01107145

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-01-31

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.

Conditions

Plasmodium Vivax Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mefloquine- Artesunate

Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.

Group Type: EXPERIMENTAL

Mefloquine- Artesunate

Intervention Type: DRUG

Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.

Artemether-Lumefantrine

Artemether-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

Group Type: EXPERIMENTAL

Artemether-Lumefantrine

Intervention Type: DRUG

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

Chloroquine (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)

Group Type: ACTIVE_COMPARATOR

Chloroquine

Intervention Type: DRUG

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

Mefloquine- Artesunate

Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.

Intervention Type: DRUG

Artemether-Lumefantrine

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

Intervention Type: DRUG

Chloroquine

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)

Intervention Type: DRUG

Other Intervention Names

Artesunato-Mefloquina (Farmaguinhos, Brazil); Coartem, Novartis; Lumet, Cipla; Chloroquine (Farmaguinhos, Brazil)

Eligibility Criteria

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 delivery
• 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, 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meghna Desai, MPH PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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

Countries

Brazil

Other Identifiers

PAACT-PV

Identifier Type: -

Identifier Source: org_study_id