Drug Interaction Study Between Antimalarial and Anti-HIV Medications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fran Aweeka, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00266058
First received: December 14, 2005
Last updated: June 4, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Malaria
Drug: Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pharmacokinetic Interactions Between Antiretroviral Agents, Lopinavir/Ritonavir and Efavirenz and Antimalarial Drug Combination, Artemether/Lumefantrine

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Pharmacokinetic assessment of potential drug-drug interactions of antimalarials and antiretroviral agents. [ Time Frame: Intensive serial PK sampling of antimalarials conducted on study day 4 (without antiretrovirals) and study day 31 (in the context of antiretrovirals ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: December 2005
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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)
Active Comparator: efavirenz, artemether, lumefantrine
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
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266058

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Francesca Aweeka, Pharm.D. University of California, San Francisco
  More Information

No publications provided

Responsible Party: Fran Aweeka, Prinicpal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00266058     History of Changes
Other Study ID Numbers: AAKE99
Study First Received: December 14, 2005
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
healthy
controls
research
clinical
study
pharmacokinetic
PK
HIV
malaria

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Malaria
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protozoan Infections
Parasitic Diseases
Antimalarials
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Efavirenz
Ritonavir
Lopinavir
Anti-Retroviral Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Coccidiostats

ClinicalTrials.gov processed this record on August 20, 2014