Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 1244 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00179335
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 6, 2009
Sponsor:
Collaborators:
Abbott
University of Alabama at Birmingham
Information provided by:
Albert Einstein College of Medicine

Tracking Information
First Submitted Date September 10, 2005
First Posted Date September 16, 2005
Last Update Posted Date August 6, 2009
Study Start Date August 2003
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00179335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults
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
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Residual plasma left from measurement of drug levels.
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.
Condition HIV Infections
Intervention Procedure: Blood drawing to determine drug levels
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 5, 2009)
45
Original Enrollment
 (submitted: September 10, 2005)
40
Actual Study Completion Date September 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00179335
Other Study ID Numbers CCI 03 143
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Elizabeth Jenny-Avital, Jacobi Medical Center
Study Sponsor Albert Einstein College of Medicine
Collaborators
  • 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
PRS Account Albert Einstein College of Medicine
Verification Date August 2009