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

This study has been completed.
Sponsor:
Collaborators:
Abbott
University of Alabama at Birmingham
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00179335
First received: September 10, 2005
Last updated: August 5, 2009
Last verified: August 2009
History of Changes
  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
U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: 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 of Yeshiva University
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 
Study First Received: September 10, 2005
Last Updated: August 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
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
Lopinavir
Ritonavir
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

ClinicalTrials.gov processed this record on September 26, 2016