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Vivax MalariaPhase 2NCT03529396

Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients

A Phase 2 study testing Chloroquine and Primaquine in people with Vivax Malaria and G6PD Deficiency, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 2 sites in Brazil.

Completed

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

Official record
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Trial summary

A clinical study to assess the safety and efficacy of alternative regimens of primaquine for radical cure of vivax malaria in glucose 6-phosphate dehydrogenase (G6PD) deficient. G6PD deficient patients with P. Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Vivax Malaria, G6PD Deficiency
What is being tested?
Chloroquine and Primaquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesBrazil
Study dates
20 Jul 2018to 6 Jul 2023
Phase
Phase 2
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 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Uncomplicated vivax malaria monoinfection
  • G6PD deficiency ranging from 10%-60% of adjusted mean male activity
  • Baseline hemoglobin >9 g/dL
  • Willing to comply with study requirements

Who cannot join

  • Pregnancy or breastfeeding
  • Comorbidities (hepatopathy and/or nephropathy)
  • Use of antimalarials in the previous two weeks or current use of potentially hemolytic drugs
  • Any condition which would place the subject at undue risk of hemolysis or interfere with the results of the study, as judged by investigator.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Fundação de Medicina Tropical Doutor Heitor Vieira Dourado

    Manaus, Amazonas, 69040-000

  • Centro de Pesquisa em Medicina Tropical (Cepem)

    Porto Velho, Rondônia

Other trials in Brazil

About this study

Official title: Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in Glucose 6-phosphate Dehydrogenase Deficient Patients

A clinical study to assess the safety and efficacy of alternative regimens of primaquine for radical cure of vivax malaria in glucose 6-phosphate dehydrogenase (G6PD) deficient. G6PD deficient patients with P. vivax monoinfection will be treated with either weekly or delayed one-week course of primaquine, and the currently recommended by national guideline, 12-week chloroquine regimen to compare treatment safety among groups. All groups will be actively monitored for hemolysis during treatment and will have six-month follow-up period to assess treatment efficacy.

Read the detailed description

This is an open-label, randomized, phase II, clinical trial of safety and efficacy. Patients will be screened for eligibility and treated at the Fundação de Medicina Tropical Dr Heitor Vieira Dourado in Manaus and the Centro de Pesquisa em Medicina Tropical (Cepem) in Porto Velho, Brazil. A total of 104 vivax malaria patients will be recruited into the study, 52 G6PD deficient (Arm 1) and 52 G6PD normal (Arm 2). Patients with spectrophotometrically-confirmed G6PD deficiency (10-60% of adjusted mean male activity) will be divided into three subgroups of 10 patient each. All arms will receive standard 3-day chloroquine course. Additionally, Arm 1a will receive a delayed course of primaquine for 7 days, starting only at the fifth-day post-chloroquine initiation [ARM HALTED DUE TO SAFETY CONCERNS]. Arm 1b will receive weekly primaquine, once a week, for 8 weeks. Arm 1c will receive prophylactic 12-week course of chloroquine, as recommended by national guidelines for such patients (control group in terms of safety). Arm 2, the control group of efficacy, will receive standard regimen, comprised of 3-day chloroquine plus concomitant 7-day primaquine. All patients will receive directly observed therapy (DOT) and will be closely monitored for clinical parameters and laboratory markers of hemolysis including hemoglobin, methemoglobin, lactate dehydrogenase, haptoglobin, reticulocytes, indirect bilirubin, aspartate aminotransferase, and urinalysis. All groups will be followed for 6 months after treatment to assess relapse rate. Primary endpoint is the tolerability of the regimens defined by hemoglobin fall. Secondary endpoints include treatment failure (relapse during follow-up), frequency of adverse effects, and rate of hemoglobin fall during treatment.

Being tested
Chloroquine, Primaquine
Keywords
G6PD deficiency, Acute hemolytic anemia, Vivax malaria, Primaquine, Weekly primaquine, Chloroquine, Weekly chloroquine, Brazilian Amazon, Oxidative stress
Medical subject headings
Malaria, Vivax, Glucosephosphate Dehydrogenase Deficiency

What participants receive

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

  • ChloroquineDrug

    Standard chloroquine (three days)

  • PrimaquineDrug

    Daily Primaquine (0.5 mg of base/kg/day for seven days) starting only at the fifth day post chloroquine initiation.

  • PrimaquineDrug

    Weekly primaquine (0.75 mg of base/kg/week for eight weeks) starting with first dose of chloroquine.

  • ChloroquineDrug

    Weekly, once a week chloroquine (5 mg of base/kg/week for twelve weeks)

  • PrimaquineDrug

    Standard primaquine (0.5mg of base/kg/day for seven days) concomitant with chloroquine.

Study groups in NCT03529396
Study groupRoleWhat they receive
1a: Chloroquine + 5th-day PrimaquineExperimental[ARM HALTED PREMATURELY DUE TO SAFETY CONCERNS]
Receives: Drug: Chloroquine; Drug: Primaquine
1b: Chloroquine + 8-week PrimaquineExperimental26 G6PD deficient patients. Directly observed therapy.
Receives: Drug: Chloroquine; Drug: Primaquine
1c: Chloroquine + 12-week ChloroquineActive comparator26 G6PD deficient patients. Control group in terms of safety. Directly observed therapy.
Receives: Drug: Chloroquine
2: Standard chloroquine + primaquineActive comparator52 G6PD normal patients. Control group in terms of efficacy. Directly observed therapy.
Receives: Drug: Chloroquine; Drug: Primaquine

What is being measured

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

  1. Absolute or relative change in hemoglobin < 3g/dL or 30% from baseline

    Hemoglobin reduction from baseline after exposure to primaquine for P. vivax treatment

    Measured: From date of randomization until the date of last dose, assessed up to 12 weeks.

Secondary outcomes (3)

  1. Regimen efficacy

    Relapse rate over follow-up period after treatment

    Measured: 6 months post treatment

  2. Adverse effects

    Presence of adverse reactions as a result of intervention, measured by clinical and laboratory tests

    Measured: From date of randomization until the date of first documented event, assessed up to 12 weeks.

  3. Change in hemoglobin values over treatment

    Absolute variation of hemoglobin levels before and during intervention.

    Measured: through study completion: before intervention and up to 12 weeks during intervention.

Timeline

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

  1. First posted18 May 2018
  2. Study start20 Jul 2018
  3. Primary completion20 Dec 2022
  4. Study completion6 Jul 2023

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529396
Sponsor's protocol ID
CAAE: 70177317.1.0000.0005
Status last verified
Feb 2025
First submitted
25 Apr 2018
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Barbosa L, Brito-Sousa J, Nascimento C, Pacheco A, Alexandre M, Alencar A, Melo M, Omena A, Souza I, Silva E, Queiroz M, Siqueira V, Rabelo C, Baia-da-Silva D, Silva D, Rocha Y, Barbosa A, Castro R, Almeida A, Brito M, Lopes A, Balieiro A, Costa M, Amaral T, Valle C, Vieira A, Gonzaga J, Pereira D, Alecrim M, Monteiro W, Lacerda M, Melo G. Safety and Efficacy of 3 Alternative Regimens Against Relapsing Plasmodium vivax Malaria in Glucose 6-Phosphate Dehydrogenase-Deficient Patients in the Brazilian Amazon (ALTPRIM). Clin Infect Dis. 2025 Dec 24;81(5):e294-e301. doi: 10.1093/cid/ciaf007.

    PubMed 39785834

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chloroquine and Primaquine in people with Vivax Malaria and G6PD Deficiency, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 2 sites in Brazil.

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 4 inclusion and 4 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Absolute or relative change in hemoglobin < 3g/dL or 30% from baseline (time frame: From date of randomization until the date of last dose, assessed up to 12 weeks.). 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 NCT03529396, which also lists 1 linked publication.

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 20 Feb 2025.

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