Drug Interaction Study Between Antimalarial and Anti-HIV Medications

NCT ID: NCT00266058

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2010-11-30

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 be used are artemether/lumefantrine (antimalarial medication) and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not approved by the United States Food and Drug Administration (FDA) but is recommended as standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn about whether or not the use of these medicines together results in a change in blood levels of any of these medicines. The information obtained from this study will help doctors to provide a better treatment to children and adults with malaria and HIV.

Detailed Description

The study involves 5 non-consecutive overnight stays and 14 additional outpatient visits at the San Francisco General Hospital Research Center.

Conditions

HIV Infections; Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Lopinavir/ritonavir, artemethr/lumefantrine

Determination of the antimalarial drug levels artemether/lumefantrine in the absence and in the presence of co-administered antiretrovirals lopinavir and ritonavir.

Group Type: ACTIVE_COMPARATOR

Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine

Intervention Type: DRUG

participants receive a total of 6 doses of artemether(80mg)/lumefantrine(480mg)for baseline PK evaluation. This is followed by a 26-day course of either efavirenz(600mg) once daily or lopinavir/ritonavir (400mg/100mg) twice daily and additional 6 doses of artemether/lumefantrine to determine the pharmacokinetics of the antimalarial medications in the context of antiretrovirals. The participants undergo at least a 14 day washout period (between the last baseline PK blood draw and the initiation of antiretrovirals)

efavirenz, artemether, lumefantrine

Determination of the antimalarial drug levels artemether/lumefantrine in the absence and in the presence of co-administered antiretroviral efavirenz.

Group Type: ACTIVE_COMPARATOR

Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine

Intervention Type: DRUG

participants receive a total of 6 doses of artemether(80mg)/lumefantrine(480mg)for baseline PK evaluation. This is followed by a 26-day course of either efavirenz(600mg) once daily or lopinavir/ritonavir (400mg/100mg) twice daily and additional 6 doses of artemether/lumefantrine to determine the pharmacokinetics of the antimalarial medications in the context of antiretrovirals. The participants undergo at least a 14 day washout period (between the last baseline PK blood draw and the initiation of antiretrovirals)

Interventions

Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine

participants receive a total of 6 doses of artemether(80mg)/lumefantrine(480mg)for baseline PK evaluation. This is followed by a 26-day course of either efavirenz(600mg) once daily or lopinavir/ritonavir (400mg/100mg) twice daily and additional 6 doses of artemether/lumefantrine to determine the pharmacokinetics of the antimalarial medications in the context of antiretrovirals. The participants undergo at least a 14 day washout period (between the last baseline PK blood draw and the initiation of antiretrovirals)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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.
• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Fran Aweeka

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesca Aweeka, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

AAKE99

Identifier Type: -

Identifier Source: org_study_id