Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults
This study is currently recruiting participants.
Verified by Albert Einstein College of Medicine of Yeshiva University, August 2003
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
Abbott
University of Alabama at Birmingham
Information provided by: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00179335
  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

MedlinePlus related topics: AIDS
Drug Information available for: Efavirenz Ritonavir Lopinavir
U.S. FDA Resources
Study Type: Observational
Study Design: Cross-Sectional, Case Control, Prospective Study
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

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

Estimated Enrollment: 40
Study Start Date: August 2003
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179335

Contacts
Contact: Elizabeth R Jenny-Avital, MD 718-918-3657 elizabeth.jenny-avital@nbhn.net

Locations
United States, New York
Jacobi Medical Center ACS Clinic Recruiting
Bronx, New York, United States, 10461
Contact: Elizabeth R Jenny-Avital, MD     718-918-3657     elizabeth.jenny-avital@nbhn.net    
Principal Investigator: Elizabeth R Jenny-Avital, MD            
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

Study ID Numbers: CCI 03 143
Study First Received: September 10, 2005
Last Updated: October 11, 2006
ClinicalTrials.gov Identifier: NCT00179335  
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+

Study placed in the following topic categories:
Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009