Comparative Pharmacokinetics (PK) Study of Efavirenz or Lopinavir/Ritonavir Between Older and Younger HIV-Infected Adults
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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 |
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) |
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 |
| Sampling Method: | 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.
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| United States, New York | |
| Jacobi Medical Center ACS Clinic | |
| Bronx, New York, United States, 10461 | |
| 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
No publications provided
| 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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Lopinavir |
Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on March 03, 2013
