Status:
COMPLETED
Drug Interaction Study Between Antimalarial and Anti-HIV Medications
Lead Sponsor:
University of California, San Francisco
Conditions:
HIV Infections
Malaria
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out whether taking certain anti-HIV medicines with certain antimalarial medicines affects the amount of the medicines in the blood. The study medicines that will ...
Detailed Description
The study involves 5 non-consecutive overnight stays and 14 additional outpatient visits at the San Francisco General Hospital Research Center.
Eligibility Criteria
Inclusion
- Absence of HIV infection prior to study entry
- Within 20% (+/-) of ideal body weight and must weigh at least 50kg
- Healthy subjects without evidence of acute or chronic illnesses, including diabetes, high blood pressure, coronary artery disease, psychiatric illnesses, liver or kidney impairment
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.
- Pregnant or breast- feeding.
- History of acute or chronic illnesses, such as diabetes, high blood pressure, coronary artery disease, psychiatric illnesses, liver or kidney 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 electrolyte abnormalities.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00266058
Start Date
December 1 2005
End Date
November 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