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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

September 10, 2005
August 5, 2009
August 2003
January 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00179335 on ClinicalTrials.gov Archive Site
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Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Residual plasma left from measurement of drug levels.

Non-Probability Sample

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.

HIV Infections
Procedure: Blood drawing to determine drug levels
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179335
CCI 03 143
Not Provided
Elizabeth Jenny-Avital, Jacobi Medical Center
Albert Einstein College of Medicine of Yeshiva University
  • Abbott
  • University of Alabama at Birmingham
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
Albert Einstein College of Medicine of Yeshiva University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP