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

December 14, 2005
June 4, 2013
December 2005
November 2010   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00266058 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Drug Interaction Study Between Antimalarial and Anti-HIV Medications
Pharmacokinetic Interactions Between Antiretroviral Agents, Lopinavir/Ritonavir and Efavirenz and Antimalarial Drug Combination, Artemether/Lumefantrine

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • HIV Infections
  • Malaria
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: 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.
    Intervention: Drug: Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine
  • 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.
    Intervention: Drug: Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00266058
AAKE99
Not Provided
Fran Aweeka, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Francesca Aweeka, Pharm.D. University of California, San Francisco
University of California, San Francisco
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP