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

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00179335
Collaborator
Abbott (Industry), University of Alabama at Birmingham (Other)
45
Enrollment
1
Location
37
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Aug 1, 2003
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Jacobi Medical Center ACS Clinic Bronx New York United States 10461

    Sponsors and Collaborators

    • Albert Einstein College of Medicine
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Albert Einstein College of Medicine
    ClinicalTrials.gov Identifier:
    NCT00179335
    Other Study ID Numbers:
    • CCI 03 143
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Apr 26, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Albert Einstein College of Medicine
    Regular lopinavir/ritonavir or Efavirenz use
    Age >/= 55 y or </= 35 y
    HIV+
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Apr 26, 2021