A Phase 2 interventional study of DB289 and Pentamidine in African Trypanosomiasis, sponsored by Immtech Pharmaceuticals, Inc. Completed at 2 sites in Congo. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2008-12-08.
Sponsored by Immtech Pharmaceuticals, Inc · Phase 2, Interventional, and Treatment
Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control.
This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.
26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.
This study's enrollment of 111 is below the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.
Browse Trypanosomiasis, African studies →Immtech Pharmaceuticals, Inc is the lead sponsor of 5 studies on the registry; none are open to participants now.
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The human immunodeficiency virus, which weakens the immune system.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pafuramidine maleate (DB289), 100 mg BID orally
Drug: DB289
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
Drug: Pentamidine
Pafuramidine maleate (DB289), 100 mg BID orally
Also known as: pafuramidine maleate
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.
Time frame: 3 months
The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.
Time frame: 12 day
The secondary outcome measure was the incidence rate of adverse events (all Grades combined) during the 7- to 9-day observation period in Treatment Sequence 1 and during the 12-day observation period in Treatment Sequence 2.
Time frame: 12 day
The number and percentage of subjects with parasitological cure, subjects with confirmed (parasitological) treatment failure, and subjects with suspected treatment failure at 6, 12, and 24 months after completion of treatment.
Time frame: 6, 12, 24 months
The record gives a start of Feb 2003, a primary completion of Feb 2004 and a completion of Jun 2005. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pafuramidine
Immtech Pharmaceuticals, Inc