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Sponsors and Collaborators: |
Immtech Pharmaceuticals, Inc Bill and Melinda Gates Foundation |
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Information provided by: | Immtech Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00803933 |
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.
Condition | Intervention | Phase |
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African Trypanosomiasis |
Drug: DB289 Drug: Pentamidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis |
Enrollment: | 111 |
Study Start Date: | February 2003 |
Study Completion Date: | June 2005 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DB289: Experimental
Pafuramidine maleate (DB289), 100 mg BID orally
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Drug: DB289
Pafuramidine maleate (DB289), 100 mg BID orally
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Pentamidine: Active Comparator
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
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Drug: Pentamidine
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
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Ages Eligible for Study: | 15 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If the patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy):
Exclusion Criteria:
Congo, Kinshasa | |
CDTC Maluku | |
Gombe, Kinshasa, Congo | |
Vanga Hospital | |
Gombe, Kinshasa, Congo |
Principal Investigator: | Victor Kande, MD | Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine |
Responsible Party: | Swiss Tropical Institute ( Christian Burri, Study Director ) |
Study ID Numbers: | 289-C-006 |
Study First Received: | December 4, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00803933 History of Changes |
Health Authority: | United States: Food and Drug Administration |
first stage Trypanosoma brucei gambiense T. b. gambiense sleeping sickness First stage T. b. gambiense sleeping sickness |
Protozoan Infections Clotrimazole Miconazole Antifungal Agents Tioconazole |
Trypanosomiasis, African Trypanosomiasis Pentamidine Parasitic Diseases |
Trypanocidal Agents Protozoan Infections Anti-Infective Agents Antiprotozoal Agents Trypanosomiasis, African Mastigophora Infections Pharmacologic Actions |
Antiparasitic Agents Antifungal Agents Therapeutic Uses Trypanosomiasis Sarcomastigophora Infections Parasitic Diseases Pentamidine |