Weekly Dosing of Malarone ® for Prevention of Malaria

NCT ID: NCT00984256

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-04-30

Brief 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.

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.

Conditions

Malaria

Keywords

Malaria; Prophylaxis; Atovaquone; Malarone; Challenge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Drug

5 groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.

Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge

Group Type: EXPERIMENTAL

Atovaquone Proguanil

Intervention Type: DRUG

Volunteers will receive doses of atovaquone/proguanil (Malarone) or matching sugar pills.

Procedure - malaria challenge

Intervention Type: OTHER

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.

Control -no prophylaxis

Group Type: PLACEBO_COMPARATOR

Procedure - malaria challenge

Intervention Type: OTHER

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.

Interventions

Atovaquone Proguanil

Volunteers will receive doses of atovaquone/proguanil (Malarone) or matching sugar pills.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Malaria; Prophylaxis; Atovaquone; Malarone; Challenge; Malaria; Prophylaxis; Atovaquone; Malarone; Challenge

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Deye, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Institute of Research (WRAIR)

Locations

Walter Reed Army Institute of Research

Silver Spring, Maryland, United States

Countries

United States

References

Deye GA, Miller RS, Miller L, Salas CJ, Tosh D, Macareo L, Smith BL, Fracisco S, Clemens EG, Murphy J, Sousa JC, Dumler JS, Magill AJ. Prolonged protection provided by a single dose of atovaquone-proguanil for the chemoprophylaxis of Plasmodium falciparum malaria in a human challenge model. Clin Infect Dis. 2012 Jan 15;54(2):232-9. doi: 10.1093/cid/cir770. Epub 2011 Nov 3.

Reference Type: RESULT

PMID: 22052893 (View on PubMed)

Other Identifiers

HSRRB # A-15648

Identifier Type: OTHER

Identifier Source: secondary_id

WRAIR 1583

Identifier Type: -

Identifier Source: org_study_id