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| Tracking Information | |||||||||
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| First Received Date † | September 10, 2005 | ||||||||
| Last Updated Date | October 11, 2006 | ||||||||
| Start Date † | August 2003 | ||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | Complete list of historical versions of study NCT00179335 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cross-Sectional, Case Control, Prospective Study | ||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | Procedure: Blood drawing to determine drug levels | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 40 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00179335 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Albert Einstein College of Medicine of Yeshiva University | ||||||||
| Collaborators †† |
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| Investigators † |
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| Information Provided By | Albert Einstein College of Medicine of Yeshiva University | ||||||||
| Verification Date | August 2003 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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