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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00179335
Enrollment
45
Registered
2005-09-16
Start date
2003-08-31
Completion date
2006-09-30
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Regular lopinavir/ritonavir or Efavirenz use, Age >/= 55 y or </= 35 y, HIV+

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.

Interventions

PROCEDUREBlood drawing to determine drug levels

Sponsors

Abbott
CollaboratorINDUSTRY
University of Alabama at Birmingham
CollaboratorOTHER
Albert Einstein College of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026