Weekly Dosing of Malarone ® for Prevention of Malaria

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Atovaquone; Atovaquone, proguanil drug combination; Proguanil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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