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Drug Interaction Study Between Antimalarial and Anti-HIV Medications
This study has been completed.
Sponsor:
University of California, San Francisco
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
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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 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 Fran Aweeka, 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 ]
| 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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
| 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 |
Keywords provided by Fran Aweeka, University of California, San Francisco:
|
healthy controls research clinical study |
pharmacokinetic PK HIV malaria |
Additional relevant MeSH terms:
|
HIV Infections Malaria Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Protozoan Infections Parasitic Diseases Ritonavir Lopinavir Efavirenz |
Lumefantrine Artemether Artemether-lumefantrine combination Artemisinins Antimalarials Anti-Retroviral Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 24, 2017