Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00179335

First Posted: September 16, 2005

Last Update Posted: August 6, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Abbott

University of Alabama at Birmingham

Information provided by:

Albert Einstein College of Medicine, Inc.

Purpose

HIV infected patients, aged </= 35 years and aged >/= 55 years, who are regularly taking either efavirenz (EFV) or lopinavir/ritonavir (Lop/r) as part of their antiretroviral regimen are being asked to spend 12 hours at the researchers' clinic (the ACS clinic at Jacobi Medical Center, Bronx, New York) for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period. Patients taking EFV will return for one additional blood draw the following day.

Condition	Intervention
HIV Infections	Procedure: Blood drawing to determine drug levels


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Cross Sectional Case-Sectional Control Pharmacokinetic Study of Efavirenz or Lopinavir/Ritonavir as Part of an Antiretroviral Regimen With Two Nucleosides in HIV-Infected Adults 55 Years of Age or Older Compared With Adults Aged 18-35 Years

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Efavirenz Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine, Inc.:

Biospecimen Retention: Samples Without DNA

Residual plasma left from measurement of drug levels.


Enrollment:	45
Study Start Date:	August 2003
Study Completion Date:	September 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Detailed Description:

HIV infected patients, aged </= 35 years and aged >/= 55 years, who are regularly taking either efavirenz or lopinavir/ritonavir as part of their antiretroviral regimen are being asked to spend 12 hours at our clinic (the ACS clinic at Jacobi Medical Center, Bronx, NY) for an intensive pharmacokinetic study in which 5 cc of blood will be drawn 9 times over a 12 hour period. Patients taking EFV will return for one additional blood draw the following day.

Patients will be asked to come to the clinic at 7 am and bring their medication to the clinic. Blood will be drawn to obtain a trough level of either EFV or Lop/r after which the patient will be instructed to take their EFV or Lop/r. Then blood will be drawn 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours later. Patients on EFV will be asked to return the next morning for a 24 hour blood level.

The blood will be spun and the plasma frozen at - 70 C. The plasma samples, labelled with the patients' initials and the draw date, will be shipped to University of Alabama, Department of Pharmacology, where the drug levels will be measured.

Patients will be recruited from the ACS outpatient clinic. They will be identified by their providers.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pts enrolled in our clinic who are on either lopinavir/ritonavir or efavirenz, who are tolerating their HIV meds and who are judged to be compliant.

Criteria

Inclusion Criteria:

HIV+
Taking lopinavir/ritonavir or efavirenz
Age </= 35 years or >/= 55 years

Exclusion Criteria:

Concurrent therapy with drugs that alter lopinavir/ritonavir levels.
Other renal or kidney disease.
Chronic hepatitis B or C

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179335

Locations


United States, New York
Jacobi Medical Center ACS Clinic
Bronx, New York, United States, 10461

Sponsors and Collaborators

Albert Einstein College of Medicine, Inc.

Abbott

University of Alabama at Birmingham

Investigators


Principal Investigator:	Elizabeth R Jenny-Avital, MD	Jacobi Medical Center, Albert Einstein College of Medicine
Principal Investigator:	Edward Acosta, Pharm D	University of Alabama at Birmingham

More Information


Responsible Party:	Elizabeth Jenny-Avital, Jacobi Medical Center
ClinicalTrials.gov Identifier:	NCT00179335 History of Changes
Other Study ID Numbers:	CCI 03 143
First Submitted:	September 10, 2005
First Posted:	September 16, 2005
Last Update Posted:	August 6, 2009
Last Verified:	August 2009

Keywords provided by Albert Einstein College of Medicine, Inc.:


Regular lopinavir/ritonavir or Efavirenz use Age >/= 55 y or </= 35 y HIV+

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers

HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers

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