CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
LPV/rdrug
Likely dose
LPV/r 800/200 mg once dailyAI-extracted
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Confirmed HIV infection by ELISA and Western blot
  • ✓Currently taking LPV/r 400/100 mg twice daily for ≥3 months
  • ✓HIV RNA <400 copies/ml within last 90 days
Key exclusion· 5
  • ✕Hepatic abnormality (ALT, AST, or total bilirubin ≥3× upper limit of normal)
  • ✕Renal insufficiency (serum creatinine ≥2 mg/dl)
  • ✕Co-infection with hepatitis B and/or C
  • ✕Pregnancy or breastfeeding

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00148759
NCT00148759Phase 4Completed
CompareCT.gov

A Switch From Twice Daily to Once Daily Lopinavir/Ritonavir: A 24-hour Pharmacokinetic Profile to Evaluate Sex Differences

Emory University·interventional·Posted Sep 8, 2005·Updated Dec 3, 2013

In Brief

A Phase 4 clinical trial evaluating LPV/r for HIV Infections. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartJun 1, 2005
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.8 years ago

Interventions

LPV/rdrug

LPV/r 800/200 mg once daily