Kaletra Monotherapy in HIV/HCV Co-infected Subjects
NCT00508222 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2012-05-30
Summary
The study has been designed to test the hypothesis that in patients co-infected with HIV and HCV who exhibit maximal virologic suppression on a double class antiretroviral (ARV) regimen, including two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) or a Protease Inhibitor (PI) (boosted or not with ritonavir), simplification of highly active antiretroviral therapy (HAART) to Kaletra® monotherapy will represent a viable strategy without any negative impact on the virologic control of HIV infection.
Conditions
- HIV Infections
Interventions
- DRUG
-
Kaletra Tablets
Kaletra 800/200 OD
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ottawa Hospital Research Institute
lead OTHER
Principal Investigators
-
Curtis Cooper, MD · OHRI
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2011-03-31
- Completion
- 2011-04-30
Countries
- Canada
Study Locations
More Related Trials
-
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
NCT01328158 ·Status: COMPLETED
-
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
NCT00234910 ·Status: COMPLETED ·Phase: PHASE3
-
Drug Use Investigation of Kaletra
NCT01076972 ·Status: COMPLETED
-
Kaletra and Viread in Antiretroviral Naïve Patients
NCT00679926 ·Status: TERMINATED ·Phase: PHASE4
-
Surveillance of Kaletra in Korean Patients
NCT01083173 ·Status: COMPLETED
-
A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
NCT00121017 ·Status: WITHDRAWN ·Phase: PHASE2
-
Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs)
NCT01103596 ·Status: COMPLETED
-
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
NCT00052117 ·Status: COMPLETED ·Phase: PHASE2
-
High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease
NCT00247143 ·Status: UNKNOWN ·Phase: NA
-
A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
NCT01045369 ·Status: COMPLETED ·Phase: PHASE4
-
Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) in HIV Positive Adult Patients
NCT00116636 ·Status: COMPLETED ·Phase: PHASE2
-
Kaletra-isentress Treatment Evaluation
NCT00700115 ·Status: COMPLETED ·Phase: PHASE4
-
Kaletra: Therapy With Double Protease Inhibitors
NCT01075191 ·Status: COMPLETED
-
Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score
NCT00234975 ·Status: COMPLETED ·Phase: PHASE4
-
A Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects
NCT00075231 ·Status: COMPLETED ·Phase: PHASE2
-
Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
NCT00038519 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
NCT01379703 ·Status: COMPLETED
-
Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy
NCT00234962 ·Status: TERMINATED ·Phase: PHASE4
-
Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients
NCT00661349 ·Status: TERMINATED ·Phase: PHASE4
-
GW873140 In Combination With Kaletra In HIV Infected Subjects
NCT00102778 ·Status: TERMINATED ·Phase: PHASE2
-
Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
NCT00038220 ·Status: COMPLETED ·Phase: PHASE2
-
BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)
NCT00414284 ·Status: TERMINATED ·Phase: PHASE4
-
NRTI-Sparing Pilot Study
NCT00143689 ·Status: COMPLETED ·Phase: PHASE4
-
Lopinavir Capsules to Kaletra or Invirase Tablets
NCT00438152 ·Status: COMPLETED ·Phase: PHASE4
-
Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
NCT00038532 ·Status: COMPLETED ·Phase: PHASE2