Prophylactic Antimalarial Activity of DB289 in Volunteers

This study has been completed.
Sponsor:
Information provided by:
Immtech Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00408369
First received: December 4, 2006
Last updated: January 25, 2008
Last verified: January 2008
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prophylactic Antimalarial Activity of DB289 in Volunteers Challenged With Plasmodium Falciparum

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Immtech Pharmaceuticals, Inc:
prophylactic
malaria
challenge

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014