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

This study has been terminated.
(Extremely slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01107145
First received: April 19, 2010
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Plasmodium Vivax Malaria
Drug: Mefloquine- Artesunate
Drug: Artemether-Lumefantrine
Drug: Chloroquine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 63-day PCR-adjusted parasitological cure of P. vivax [ Time Frame: 63 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mefloquine- Artesunate
Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Drug: Mefloquine- Artesunate
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Other Name: Artesunato-Mefloquina (Farmaguinhos, Brazil)
Experimental: 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
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
Other Names:
  • Coartem, Novartis
  • Lumet, Cipla
Active Comparator: 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)
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)
Other Name: Chloroquine (Farmaguinhos, Brazil)

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107145

Locations
Brazil
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
Sponsors and Collaborators
Investigators
Principal Investigator: Meghna Desai, MPH PhD Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01107145     History of Changes
Other Study ID Numbers: PAACT-PV
Study First Received: April 19, 2010
Last Updated: April 12, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board
Brazil: National Committee of Ethics in Research

Keywords provided by Centers for Disease Control and Prevention:
Plasmodium
Vivax
Malaria
Pregnancy
Brazil
Treatment

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Chloroquine
Artesunate
Chloroquine diphosphate
Mefloquine
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics

ClinicalTrials.gov processed this record on August 26, 2014