Phase 2
N=36
Weekly Dosing of Malarone ® for Prevention of Malaria
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00984256 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Prophylactic Efficacy of 3 Different Doses of Atovaquone/Proguanil (Malarone@) Given 1 Week Before Infectious Sporozoite Challenge Using the P. Falciparum Human Challenge Model. — 6; 4; 3; 6 participants with negative parasitemia
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atovaquone Proguanil (Drug); Procedure - malaria challenge (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prophylactic Efficacy of 3 Different Doses of Atovaquone/Proguanil (Malarone@) Given 1 Week Before Infectious Sporozoite Challenge Using the P. Falciparum Human Challenge Model. |
6; 4; 3; 6; 5; 0 | — |
| SECONDARY Measured Concentrations of Plasma Atovaquone With Determinations of T1/2. |
3.3; 3.3; 3.3; 5.6; 3.7 | — |
| SECONDARY Measured Concentrations of Plasma Atovaquone With Determinations of Area Under the Curve |
3595; 616; 510; 1434; 2233 | — |
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
Data sourced from ClinicalTrials.gov (NCT00984256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.