Chloroquine (CQ) and Azithromycin (AZ) Combination for Malaria Prophylaxis

Exclusion Criteria

• •Subjects with a history or presence of gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• •Subjects with a history of retinopathy, sickle cell disease or trait, psoriasis, or porphyria.
• •Subjects who take certain prescribed or over the counter (OTC) concomitant medication including: ampicillin, antacids (including kaolin), cimetidine, digoxin, ergot alkaloids, statins (HMG-CoA reductase inhibitors), cyclosporine, warfarin, fluconazole, nelfinavir, or rifabutin, within 2 weeks of dosing start, and during the duration of the study.
• •Are known or suspected of drinking too much alcohol (for men, more than 28 standard alcohol drinks and for women more than 21 standard alcohol drinks per week (standard drink is defined as a 12 oz beer, 5 oz glass of wine, or 1.5 oz of distilled spirit)
• •Positive urine drug screen for amphetamine, methamphetamine, cocaine, and opioids at screening.
• •Subjects who have donated more than 1500 mL (males) or 1000 mL (females) blood in the previous 12 months, including the maximum volume of blood (328 mL) to be taken in this study.
• •Subjects who are currently enrolled in another study involving an investigational product, or if recently involved in another clinical trial which has ended, have not received any investigational products within the past 3 months or 5 half-lives (whichever is longer) from the time of screening.
• •Any history of malaria infection in the past 3 years.
• •History of travel to malaria endemic areas in the 3 months prior to day of challenge, or plans to travel to malaria endemic areas during the duration of the study (56 days post challenge).
• •Any history of receiving a malaria vaccine
• •History of receipt of malaria prophylaxis during the 2 months prior to day of challenge
• •History of use of any antibiotics with significant antimalarial activity (examples include tetracycline, doxycycline, clindamycin, azithromycin, and sulfa drugs) during the course of the study period
• •Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening or plans to become pregnant or breastfeed from the time of enrollment until three months after challenge
• •Allergy to antimalarial drugs or use of medications known to interact with CQ
• •Significant (e.g., systemic) hypersensitivity reactions to mosquito bites (local hypersensitivity reactions at the site of mosquito bites are not an exclusion criterion)
• •History of splenectomy
• •Any confirmed or suspected immunodeficiency, including HIV infection, or taking immunosuppressive medications
• •Acute or chronic, ally significant, pulmonary, cardiovascular, endocrine, hepatic, or renal functional abnormality, as determined by history, physical examination, or laboratory evaluation
• •Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
• •Any abnormal baseline laboratory screening tests listed below
• •1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above twice the upper limit of normal for the reference lab
• •2. Creatinine above normal range
• •3. Hemoglobin out of normal range
• •4. Platelet count out of normal range
• •5. Total white blood cell (WBC) count out of normal range Note: If screening lab values are out of the normal range but are expected to be temporary (e.g. due to dehydration), they may be re-assessed one time at the discretion of the investigator.
• •Seropositive for Human immunodeficiency virus (HIV) or Hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) positive
• •An abnormal baseline screening ECG suggestive of cardiac disease as determined by a clinical investigator. QTcF of \>450 msec for males and \>470 msec for females.
• •Any other significant finding that in the opinion of the PI would increase the risk of having an adverse outcome from participating in this study