The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.

Condition	Treatment or Intervention	Phase
Plasmodium falciparum Malaria	Drug: Azithromycin/Chloroquine  Drug: Chloroquine	Phase II

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Healthy adult: male or female
• Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 – 30,000 parasites/μL
• Age 18 years to 60 years
• Willingness to sign and ability to understand consent form
• Willingness and ability to return for scheduled follow up visits

Exclusion Criteria:

• Mixed malaria infection by Giemsa smear
• History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin)
• Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study
• Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting)
• Inability to swallow oral medication
• Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality
• Any situation which could prevent the patient from returning to follow up visits
• Pregnancy or breast feeding
• Any other concurrent illness that may confound the result
• Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study

Call:      734-622-7600    ClinicalTrials.gov@Pfizer.com

Kenya
      Pfizer Investigational Site, Kisumu,  Kenya

Study ID Numbers:  A0661121
Record last reviewed:  October 2004
Record first received:  May 12, 2004
ClinicalTrials.gov Identifier:  NCT00082563
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20