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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
HIV Infections	Procedure: Blood drawing to determine drug levels

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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	45 participants
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
Study Start Date :	August 2003
Actual Primary Completion Date :	January 2006
Actual Study Completion Date :	September 2006

Groups and Cohorts

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Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA

Residual plasma left from measurement of drug levels.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 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