Status:
COMPLETED
Prophylactic Antimalarial Activity of DB289 in Volunteers
Lead Sponsor:
Immtech Pharmaceuticals, Inc
Conditions:
Prophylactic Activity Against Malaria
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the prophylactic activity of orally administered DB289 against Plasmodium falciparum in non-immune healthy volunteers who are challenged by the bite of five P. falciparum-infected Anophele...
Detailed Description
The primary endpoint of this study is the appearance of erythrocytic parasites (parasitemia), which indicates a prophylaxis failure. Parasitemia will be sought by multiple means, including blood cultu...
Eligibility Criteria
Inclusion
- Age between 18 and 45 years
- BMI between 19 and 30 (Appendix IV)
- Able to provide home address and phone number; work description, address, and phone number; and to provide the name, address, and phone number of a person willing and able to assist the investigators in making contact with the cognate volunteer during the study period
- Able and willing to follow-up intensively for 3 months of scheduled visits
- Post-menopausal or surgically sterilized women
- Score of 80% or more on a written exam to test malaria knowledge and comprehension of the study
- Serum and red cells support growth of P. falciparum in vitro (Appendix V)
- Blood type A or O
- Able and willing to provide written informed consent for screening, HIV testing, and study participation-
Exclusion
- Clinically significant abnormalities on screening examinations
- AST, ALT, bilirubin, hemoglobin, hematocrit, prothrombin time, partial thromboplastin time, or creatinine outside the limits of normal as defined at the time of testing by the Johns Hopkins Medical Laboratories
- laboratory evidence of HIV infection or active viral hepatitis
- G6PD deficiency, or hemoglobin S or C
- Significant medical illnesses requiring systemic treatment and/or hospitalization within one month of enrollment
- History of chronic medical illnesses, significant in the investigators' judgment
- Self-described use of tobacco
- History of alcohol or drug abuse
- Use of prescribed or over-the-counter medications or nutritional supplements within two weeks of enrollment (vitamins, at or below the daily recommended dose, may be taken during the study)
- Women of childbearing potential
- Blood or plasma donation within 2 weeks of enrollment
- History of malaria or residence in a malaria-endemic area
- Allergy to mosquito bites
- Intolerance to chloroquine, Malarone, quinine, quinidine, or tetracycline
- Taken anti-infective drugs or quinine-containing beverages in the week prior to enrollment
- Currently participating in other clinical trials, participated in a drug trial within two weeks of enrollment, or plan to participate in another clinical trial within three months from challenge
- Any factors for which the investigator believes that participation of the volunteer in the study is not appropriate
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00408369
Start Date
November 1 2006
End Date
November 1 2007
Last Update
January 29 2008
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205-2186