Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to justify an IND and formal phase II evaluation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Walter Reed Army Institute of Research (WRAIR)
• Treatments: Chloroquine; Tinidazole

Criteria

Inclusion Criteria:

• Adult male and non-pregnant female volunteers that can communicate in the Burmese or Karen language.

• Age: Between 18 and 65 years (inclusive).

• Acute, symptomatic, blood smear positive diagnosis of Plasmodium vivax mono-infection.

• Ability to comprehend and comply with the requirements of the protocol.

• Willing to provide written informed consent.

• Willing to abstain from alcohol (EtOH) use during initial treatment and for 72 hours thereafter.

• Sexually active females must test negative on urine pregnancy test and must be counseled on an effective method of avoiding pregnancy (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or Depo-Provera®), be surgically sterile, be post-menopause for at least one year, or be monogamous with a sterile sexual partner for at least 15 days prior to dosing with study product and at least 72 hours after their last dose of test drug.

Exclusion Criteria:

• Subjects positive for G6PD deficiency.

• Pregnant women (clinically or by positive urine β-HCG) and nursing mothers.

• Concomitant use of metronidazole, albendazole or mebendazole.

• Any malaria treatment or use of azithromycin or other macrolides, tetracyclines, sulfonamides, doxycycline, tetracycline or other sulfa based or other drug with antimalarial activity for the previous 4 weeks prior to screening. Additionally, concomitant use of phenobarbitol, rifampin, phenytoin, fosphenytoin, cimetidine, ketoconazole, cholestryramine constitute exclusion criteria.

• Significant health problems, including, but not limited to significant, cardiac, renal or liver disease or lab abnormalities and those subjects in whom it is suspected that they will not abstain from alcohol use during treatment and for the subsequent 3 days.

• Mixed malaria infection on admission determined by malaria smear and/or any positive HRP2 antigen testing.

• A previous history of significant intolerance or hypersensitivity to the study drug tinidazole or to chloroquine or primaquine. (nausea alone from previous primaquine use will not be an excluding factor unless subject was unable to complete a primaquine course due to this discomfort.)

• Subjects that have received transfusions within the previous 30 days.

• Presenting hematocrit <25%.