Weekly Dosing of Malarone ® for Prevention of Malaria

Completed · Phase 2

Conditions studied: Malaria

In brief

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.

Key facts

Study ID

NCT00984256

Run by

U.S. Army Medical Research and Development Command

People needed

35

Starts

2009-09-01

Expected to finish

2010-04-01

Last updated by the study team

2013-11-25

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Walter Reed Army Institute of Research — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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