Weekly Dosing of Malarone ® for Prevention of Malaria
Condition: Malaria
MeSH terms: Malaria
Intervention: Atovaquone Proguanil; Procedure - malaria challenge
Intervention description: Volunteers will receive doses of atovaquone/proguanil (Malarone) or matching sugar pills.; 2) Procedure- Malaria Challenge- Volunteers will be exposed to bites of infectious mosquitoes with the intention of causing malaria infection. Volunteers infected with malaria will undergo approved treatments for malaria.
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Malaria; Prophylaxis; Atovaquone; Malarone; Challenge

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.
    

Eligibility 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