Weekly Dosing of Malarone ® for Prevention of Malaria (MALWEEK)
This study has been completed.
Sponsor:
U.S. Army Office of the Surgeon General
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00984256
First received: September 24, 2009
Last updated: April 27, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: Atovaquone Proguanil Other: Procedure - malaria challenge |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Pilot Evaluation of Weekly Dosing of Atovaquone/Proguanil (Malarone ®) for Malaria Chemoprophylaxis |
Resource links provided by NLM:
Further study details as provided by Walter Reed Army Institute of Research (WRAIR):
Primary Outcome Measures:
- Blood samples from volunteers will be analyzed for the presence of malaria parasites. The percent of volunteers in each arm protected from malaria will be calculated.
Secondary Outcome Measures:
- Drug levels of atovaquone associated with protection from malaria, blood levels of atovaquone, proguanil and metabolites of these drugs will be measured.
| Enrollment: | 36 |
| Study Start Date: | September 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Drug |
Drug: Atovaquone Proguanil
Volunteers will receive doses of atovaquone/proguanil (Malarone) or matching sugar pills.
Other Names:
Other: Procedure - malaria challenge
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.
Other Names:
|
| Experimental: Procedure - malaria challenge |
Other: Procedure - malaria challenge
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.
Other Names:
|
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 will receive a different dose of Malarone®, a drug known to prevent malaria when taken daily. Each of these doses will be lower than the maximum approved dose of this medicine. The other group will not be treated with any drug that could prevent symptoms or infection.
After exposure, both groups will be monitored for a period of approximately 3 months to see if they develop symptoms of malaria. Any subjects who do so will be treated with appropriate medications. Subjects in both groups will have their blood checked regularly during this period for the presence of malaria parasites. At the completion of the study, results will be analyzed to determine whether any of the doses of Malarone might effectively prevent malaria if taken weekly rather than daily.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984256
Locations
| United States, Maryland | |
| Walter Reed Army Institute of Research | |
| Silver Spring, Maryland, United States, 20910 | |
Sponsors and Collaborators
U.S. Army Office of the Surgeon General
Investigators
| Principal Investigator: | Gregory Deye, MD | Walter Reed Army Institute of Research (WRAIR) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00984256 History of Changes |
| Other Study ID Numbers: | WRAIR 1583, HSRRB # A-15648 |
| Study First Received: | September 24, 2009 |
| Last Updated: | April 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Walter Reed Army Institute of Research (WRAIR):
|
Malaria Prophylaxis Atovaquone Malarone Challenge |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Proguanil Atovaquone Malarone Antimalarials Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013