High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease
Recruitment status was Recruiting
The purpose of this study is to evaluate the safety, tolerability and efficacy of higher doses of lopinavir/ritonavir, in combination with other anti-HIV medications when administered as either the capsule or liquid formulations, among patients who have not had full viral suppression despite treatment with 3 classes of HIV medications, and at least 2 prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics of the active agents, lopinavir and ritonavir will be measured following administration of both the liquid and capsule formulations and compared.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Open Label Non-Comparative Study of the Safety, Efficacy and Tolerability of High Dose Ritonavir/Lopinavir Liquid in Salvage Therapy for PI Resistant HIV & a PK Equivalence Sub-Study of High Dose Ritonavir/Lopinavir Capsules|
- To evaluate the safety and efficacy of high dose kaletra liquid and capsules in the treatment of highly antiretroviral experienced, protease inhibitor resistant HIV disease.
- To compare traditional pharmacokinetic measures of the two formulations (kaletra liquid and kaletra capsules) in a subset of the patients included in the primary analysis.
|Study Start Date:||October 2005|
This study is a safety, efficacy, and tolerability study of high dose kaletra in patients who have failed multiple antiretroviral regimens, including prior treatment with 3 classes of antiretroviral drugs (nucleoside/nucleotide analogues, non-nucleoside analogues, and at least one protease inhibitor based ARV regimen), in conjunction with optimized background therapy. Patients will initially be treated with high dose kaletra capsules and optimized background therapy for 4 weeks and then switched to equivalent doses of high dose kaletra liquid formulation for a total duration of therapy of 24 weeks. The primary endpoint of the study will be the average HIV RNA change from baseline through 24 weeks (HIV RNA AACUMB). Secondary endpoints will include the proportion achieving HIV RNA < 50 and HIV RNA < 400 copies/mL at 24 weeks. Changes in CD4 from baseline, change in LPV fold change in phenotypic resistance testing, changes in fasting metabolic parameters, assessment of safety at week 24 based upon hematology, chemistry, liver function, lipid levels, proportion of patients reporting adverse events and proportion of patients with SAEs, and demonstration of bioequivalence by 12 hour pharmacokinetic measurements.
|Contact: Harry W. Lampiris, M.D.||firstname.lastname@example.org|
|Contact: Sandra Charles, R.N.||415-221-4810 ext email@example.com|
|United States, California|
|San Francisco VA Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Principal Investigator: Harry W. Lampiris, M.D.|
|Principal Investigator:||Harry W. Lampiris, M.D.||San Francisco Veterans Affairs Medical Center|