Status:
COMPLETED
Weekly Dosing of Malarone ® for Prevention of Malaria
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.
Detailed Description
In this study, two groups of volunteers will be exposed to malaria through the bites of infected mosquitoes. In one group, volunteers will be randomly assigned to one of 5 arms. Each of these arms wil...
Eligibility Criteria
Inclusion
- A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening
- Free of clinically significant health problems
- Baseline ECG before entering into the study
- Available to participate for duration of study (approximately 4 months, not including screening period)
- If the participant is female, not pregnant or lactating and willing to use contraception to prevent pregnancy
- BMI between 19 and 30
Exclusion
- History of malaria or travel to a malarious country within the previous 12 months
- History of participation in a study in which potential exposure to malaria or vaccination against malaria occurred.
- Planned travel to malarious areas during the study period.
- History of malaria chemoprophylaxis within 60 days prior to time of study entry.
- Chronic use of antibiotics with anti-malarial effects
- Chronic use (defined as more than 14 days)of immunosuppressants or other immune-modifying drugs within six months of study entry.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination, ECG or laboratory screening tests
- Significant unexplained anemia
- History of sickle cell disease or sickle cell trait
- Seropositive for hepatitis B or hepatitis C
- History of splenectomy
- Pregnant or lactating female, or female who intends to become pregnant during the study
- Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV
- History of a neuropsychiatric disorder (anxiety, depression, psychosis, schizophrenia)
- Chronic or active illicit and/or intravenous drug use
- History of allergy to atovaquone, proguanil or chloroquine
- History of psoriasis
- Concurrent participation in other research studies
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00984256
Start Date
September 1 2009
End Date
April 1 2010
Last Update
November 25 2013
Active Locations (1)
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1
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910