Status:
COMPLETED
Pharmacokinetic Interactions Between Antiretroviral Agents and Antimalarial Drug Combinations
Lead Sponsor:
Fran Aweeka
Conditions:
HIV Infections
Malaria
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine in healthy volunteers whether certain anti-HIV medications (lopinavir/ritonavir and efavirenz) affect the drug levels of certain anti-malarial medications (art...
Detailed Description
HIV and malaria are two of the most pernicious diseases facing developing countries. Malaria affects 300 to 500 million individuals annually in developing countries and it is estimated that 25.8 milli...
Eligibility Criteria
Inclusion
- Absence of HIV infection prior to study entry
- Male or female aged 21-60 who are able to provide informed consent
- Subject is within 20% (+/-) of ideal body weight and weighs at least 50 kg.
- Healthy, without evidence of acute or chronic illness including diabetes, hypertension, CAD, psychiatric illnesses, renal or hepatic impairment.
- Screening laboratory tests that are normal or deemed not clinically significant by the study physician.
- Female subjects of reproductive potential must agree to the use of two forms of birth control methods for at least one month prior to study enrollment and for 6 weeks following study completion
- Female subjects must have a negative pregnancy test within 24 hours before receiving any study drugs.
Exclusion
- Use of illicit drugs or alcohol that could interfere with the completion of the study
- Use of any over-the-counter or prescribed drugs unless approved by the principal investigator or study physician
- Use of drugs that are known to inhibit/induce CYP450 isozymes or are substrates of CYP3A4, CYP2D6, CYP2C8 enzymes (use of hormonal contraceptives is permitted).
- Pregnant or breastfeeding
- History of acute or chronic illnesses, such as diabetes, hypertension, CAD, psychiatric illnesses, renal or hepatic impairment.
- Evidence of acute illness
- Family history of congenital prolongation of QTc interval or with any conditions known to prolong QTc interval such as cardiac arrhythmias, bradycardia, or severe heart disease
- History of hypokalemia, hypomagnesemia, or hypercholesteremia
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00697892
Start Date
July 1 2005
End Date
December 1 2010
Last Update
June 6 2013
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94110