Pharmacokinetic Interactions Between Antiretroviral Agents and Antimalarial Drug Combinations

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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 (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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fran Aweeka
• Treatments: Anti-Retroviral Agents; Antimalarials; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Efavirenz; Lopinavir; Lumefantrine; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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