Drug Interaction Study Between Antimalarial and Anti-HIV Medications

NCT00266058 | Completed Phase 1

• 1 other identifier: AAKE99
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Malaria

Keywords

healthy; controls; research; clinical; study; pharmacokinetic; PK; HIV; malaria

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic assessment of potential drug-drug interactions of antimalarials and antiretroviral agents.

  Intensive serial PK sampling of antimalarials conducted on study day 4 (without antiretrovirals) and study day 31 (in the context of antiretrovirals

Study Arms (2)

Lopinavir/ritonavir, artemethr/lumefantrine

ACTIVE COMPARATOR

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

Drug: Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine

efavirenz, artemether, lumefantrine

ACTIVE COMPARATOR

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

Drug: Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine

Interventions

Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine 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)

Lopinavir/ritonavir, artemethr/lumefantrine; efavirenz, artemether, lumefantrine

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections; Malaria

Interventions

Lopinavir; Ritonavir; efavirenz; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Francesca Aweeka, Pharm.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: December 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 6, 2013

Record last verified: 2013-05

Locations

US (1)