Status:
COMPLETED
Kaletra Sex/Gender Pharmacokinetics (PK) Study
Lead Sponsor:
Emory University
Collaborating Sponsors:
Abbott
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in HIV-infected women rec...
Detailed Description
The association between patient sex and the tolerability of antiretroviral drugs (ARVs) is increasingly being recognized. Several lines of evidence suggest that women are more likely than men to devel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00148759
Start Date
June 1 2005
End Date
January 1 2007
Last Update
December 3 2013
Active Locations (1)
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1
Grady Infectious Diseases Program
Atlanta, Georgia, United States, 30308