TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

Phase 3

Completed

• Conditions: HIV Infection
• Interventions: Drug: LPV/rtv; Drug: TMC114/rtv

• Registration Number: NCT00110877
• Lead Sponsor: Tibotec Pharmaceuticals, Ireland

Brief Summary

Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

Detailed Description

Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-05-13
• Study First Submitted QC: 2005-05-13
• Study First Posted: 2005-05-16
• Primary Completion: 2007-01
• Study Completion: 2011-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

Inclusion Criteria

• Patient has documented HIV-1 infection
• Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
• Plasma HIV-1 RNA >1000 copies/mL
• General medical condition does not interfere with the assessments and the completion of the trial

Exclusion Criteria

• Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
• tenofovir, emtricitabine, atazanavir, fosamprenavir
• Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
• Life expectancy of less than 6 months
• Pregnant or breast-feeding
• Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period
• Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels
• Participation in other investigational trials without prior approval of the sponsor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
002	LPV/rtv	LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV
001	TMC114/rtv	TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV

Primary Outcome Measures

Name	Time	Method
Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)	48 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	96 weeks
Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)	96 Weeks