A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
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 which might be used as a tool to support disease control that is easily administered and has low toxicity.
This study aims to assess the efficacy of DB289, a new, oral drug for treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of more than a dozen partners from academia, industry, and the Ministries of Health of Angola and the Democratic Republic of Congo.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis|
- The primary efficacy endpoint is the parasitological cure 24 hours after completion of treatment. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- The primary outcome measure for safety analysis will be the rate of occurrence of Grade 3 or higher adverse events during the observation period. [ Time Frame: Day 12 ] [ Designated as safety issue: Yes ]
- A secondary endpoint is the parasitological cure 3, 6, 12, 24 months after completion of treatment. [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
- The secondary outcome measure will be the incidence rate of adverse events (all Grades combined) during the observation period (as compared to literature values for pentamidine). [ Time Frame: Day 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2001|
|Study Completion Date:||November 2004|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
A single 100 mg DB289 capsule will be taken by mouth twice a day, morning and evening. Drug is to be taken with a glass of water within 15 minutes of the completion of meal.
Other Name: pafuramidine maleate
This is a single-center, open label, non-controlled Phase IIa trial. Patients with first stage T.b. gambiense sleeping sickness will receive 100 mg of DB289 orally twice a day for 5 days. Subjects meeting entry criteria will be enrolled at a single site.
A total of 30 patients will be enrolled in this trial. Enrollment is planned to begin third quarter 2001 and be completed in 2-3 months.
The study will be conducted at the Trypanosomiasis Reference Center, Viana (ICCT), Angola, and at the Trypanosomiasis Treatment Center in Maluku, Congo.
|Laboratory of Reference and Investigation, Viana, ICCT|
|Bairro Ingombota, Luanda, Angola, CP 2657-C|
|Programme National de Lutte contre la Trypanosomiase|
|Kinshasa, Gombe, Congo|
|Study Director:||Christian Burri, MSc, PhD||Swiss Tropical & Public Health Institute|