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

HIV Infection Clinical Trial

Official title:

A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110877
• Other study ID #: CR002794
• Secondary ID: TMC114-C214
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2005
• Last updated: July 1, 2015
• Start date: April 2005
• Est. completion date: October 2011

Study information

• Verified date: July 2015
• Source: Tibotec Pharmaceuticals, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIreland: Irish Agriculture and Food Development AuthorityGreat Britain: Medicines and Healthcare Products Regulatory AgencyGreat Britain: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00980902

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: October 2011
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• LPV/rtv
One 400mg LPV tablet twice daily with 100mg RTV
• TMC114/rtv
Two 300mg TMC114 tablets twice daily with 100mg RTV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tibotec Pharmaceuticals, Ireland

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Denmark,  France,  Germany,  Greece,  Guatemala,  Hungary,  Malaysia,  Mexico,  Netherlands,  Panama,  Portugal,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Switzerland,  Thailand,  United Kingdom, 

References & Publications (1)

Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Béthune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)		48 weeks	No
Secondary	Number of Participants with Adverse Events		96 weeks	Yes
Secondary	Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)		96 Weeks	No