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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00148759 |
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Date of registration:
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06/09/2005 |
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Primary sponsor: |
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Public title:
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Kaletra Sex/Gender Pharmacokinetics (PK) Study: A Switch From Twice Daily to Once Daily Lopinavir/Ritonavir
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Scientific title:
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A Switch From Twice Daily to Once Daily Lopinavir/Ritonavir: A 24-Hour Pharmacokinetic Profile to Evaluate Sex Differences |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00148759 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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Countries of recruitment
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United States
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Contacts
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Name:
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Igho Ofotokun, MD, MSc |
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Address:
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Telephone:
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404-616-0659 |
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Email:
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iofotok@emory.edu |
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Affiliation:
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Name:
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Igho Ofotokun, MD, MSc |
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Address:
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Telephone:
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404-616-0659 |
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Email:
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iofotok@emory.edu |
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Affiliation:
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Name:
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Igho Ofotokun, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age greater or equal to 18 years
- Diagnosis of HIV infection as previously established by HIV Enzyme-Linked
Immunosorbent Assay (ELISA) test and confirmed by Western blot analysis.
- Must have been taking LPV/r as part of an antiretroviral regimen at a dose of 400/100
mg orally twice per day for at least 3 months.
- Recent (within last 90 days) HIV-RNA copies must be less than 400 copies/ml
Exclusion Criteria:
- Hepatic abnormality: alanine-aminotransferase (ALT), aspartate-aminotransferase (AST)
or total bilirubin (TBR) = 3 x upper limit of normal
- Renal insufficiency: serum creatinine = 2 mg/dl
- Co-infection with hepatitis B and/or C viruses
- Pregnant or breastfeeding
- Use of concurrent medications known to affect lopinavir or ritonavir concentrations
significantly.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: Kaletra
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Primary Outcome(s)
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To compare the 24-hour pharmacokinetic profile of lopinavir (LPV) following a switch from LPV/ritonavir (r) twice daily (BID) to once daily (QD) dosing among HIV-infected men and women
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Secondary Outcome(s)
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To compare the 24-hour pharmacokinetic profile of LPV following a switch from LPV/r BID to QD dosing among HIV-infected Caucasian and African American patients
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To evaluate changes in quality of life from baseline and 2 weeks following a switch from LPV/r BID to QD dosing
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To evaluate the tolerability of LPV/r (measured as toxicity grade of diarrhea) dosed BID compared with LPV/r dosed QD
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Secondary ID(s)
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GCRC0605G
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UPN 04092824
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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