Prophylactic Antimalarial Activity of DB289 in Volunteers - Full Text View

Sponsored by:	Immtech Pharmaceuticals, Inc
Information provided by:	Immtech Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00408369

Purpose

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 Anopheles stephensi mosquitoes

Condition	Intervention	Phase
Prophylactic Activity Against Malaria	Drug: DB289	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prophylactic Antimalarial Activity of DB289 in Volunteers Challenged With Plasmodium Falciparum

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: DB289

U.S. FDA Resources

Further study details as provided by Immtech Pharmaceuticals, Inc:

Primary Outcome Measures:

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 culture, polymerase chain reaction (PCR), Quantitative
Buffy Coat (QBC) analysis, and thick and thin blood smears (detailed methods,
Appendix II).

Secondary Outcome Measures:

To distinguish the mechanism of prophylaxis: causal vs suppressive
To evaluate the pharmacokinetics of DB289 and DB75
To assess the safety of DB289

Estimated Enrollment:	19
Study Start Date:	November 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

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 culture, polymerase chain reaction (PCR), Quantitative Buffy Coat (QBC) analysis, and thick and thin blood smears (detailed methods,Appendix II). QBC and giemsa-stained blood smears will be analyzed in real time and a positive result in any one of them is sufficient to initiate chloroquine treatment. All positive QBC analyses or blood smears will be confirmed by two experienced observers. On smears, the location of parasites will be recorded using a stage micrometer, and slides will be archived and available for later re-examination. PCR samples will be collected and stored for later analysis; cultures will be inoculated at once and maintained for 70 days. A positive result in any one of these tests constitutes a drug failure.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408369

Locations

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205-2186

Sponsors and Collaborators

Immtech Pharmaceuticals, Inc

Investigators

Principal Investigator:

Theresa A. Shapiro, MD, PhD

Johns Hopkins University

More Information

No publications provided

Study ID Numbers:	C06-015
Study First Received:	December 4, 2006
Last Updated:	January 25, 2008
ClinicalTrials.gov Identifier:	NCT00408369 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Immtech Pharmaceuticals, Inc:

prophylactic
malaria
challenge

Study placed in the following topic categories:

Anti-Infective Agents
Antimalarials
Protozoan Infections
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Protozoan Infections
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Parasitic Diseases
Malaria
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009