Pharmacokinetic Interactions Between Antiretroviral Agents and Antimalarial Drug Combinations

Completed · Phase 1

Conditions studied: HIV Infections, Malaria

In brief

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 (artesunate/ amodiaquine and artemether/ lumefantrine) and vice versa. Since these drugs are degraded using overlapping pathways in the liver, it is predicted that changes in both drug level and overall drug exposure will be observed.

Key facts

Study ID

NCT00697892

Run by

Fran Aweeka

People needed

38

Starts

2005-07-01

Expected to finish

2010-12-01

Last updated by the study team

2013-06-06

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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