Clinical trial NCT00110877: TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Keywords: Human Immunodeficiency Virus
Treatment Experienced
TMC114-C214
Lead sponsor: Tibotec Pharmaceuticals, Ireland
Sponsor class: INDUSTRY
First posted: 2005-05-16
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)
timeFrame: 48 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 96 weeks
measure: Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)
timeFrame: 96 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: West Hollywood
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Ft Lauderdale
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Berkley
country: United States
state: Michigan
city: Camden
country: United States
state: New Jersey
city: East Orange
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Huntersville
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: Hampton
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Rosario
country: Argentina
city: Darlinghurst
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Surry Hills
country: Australia
city: Wien N/A
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Curitiba
country: Brazil
city: Distrito Barao Geraldo-Campina
country: Brazil
city: Nova Iguacu
country: Brazil
city: Pinheiros
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Providencia
country: Chile
city: Santiago
country: Chile
city: Aalborg
country: Denmark
city: Nice
country: France
city: Paris Cedex 10
country: France
city: Paris Cedex 12
country: France
city: Paris
country: France
city: Rennes
country: France
city: Villejuif Cedex
country: France
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Hamburg
country: Germany
city: Köln
country: Germany
city: Mannheim
country: Germany
city: Osnabrück
country: Germany
city: Stuttgart
country: Germany
city: Melissia-Athens
country: Greece
city: Guatemala
country: Guatemala
city: Budapest
country: Hungary
city: Kuala Lumpur
country: Malaysia
city: Sungai Buloh
country: Malaysia
city: Guadalajara
country: Mexico
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Panama
country: Panama
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: San Juan
country: Puerto Rico
city: Kazan
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Houghton, Johannesburg
country: South Africa
city: Johannesburg
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Zurich N/A
country: Switzerland
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
city: London
country: United Kingdom
Study officials:
affiliation: Tibotec Pharmaceutical Limited
name: Tibotec Pharmaceuticals Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Bethune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58. doi: 10.1016/S0140-6736(07)61049-6.
citation: Banhegyi D, Katlama C, da Cunha CA, Schneider S, Rachlis A, Workman C, De Meyer S, Vandevoorde A, Van De Casteele T, Tomaka F. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012 Mar;10(2):171-81. doi: 10.2174/157016212799937218.