Phase 4
N=23
Kaletra Sex/Gender Pharmacokinetics (PK) Study
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00148759 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: 24-hr LPV AUC — 142,160; 152140 ng*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- LPV/r (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hr LPV AUC |
142,160; 152140 | — |
| SECONDARY 24-hr LPV Cmax |
12417; 12271 | — |
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 receiving the same dose of the drug.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00148759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.