Clinical trial NCT00359021: An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
Official title: An Open-label Trial With TMC125 as Part of an ART Including TMC114/Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial (TMC125-C206 or TMC125-C216).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1
Keywords: HIV-1
treatment experienced
virologic failure
Lead sponsor: Tibotec Pharmaceuticals, Ireland
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.

Detailed description: This is a Phase III open-label, roll-over trial to evaluate the long term tolerability, safety, antiviral and immunological effect of TMC125 as part of an individually optimized antiretroviral therapy including TMC114/rtv in HIV-1 infected patients who participated in one of the DUET (TMC125-C206 or TMC125-C216) trials. Also the change in HIV-1 resistance over time will be evaluated. This trial offers patients meeting the definition of virologic failure at Week 24 or beyond the option to roll-over to an open-label trial where they will receive TMC125 and TMC114/rtv. Three hundred patients are estimated to enroll into this trial. The withdrawal visit of the DUET trial will be the first visit of this trial. From this visit onward, all patients will receive 200 mg twice daily TMC125 and 600/100 mg twice daily TMC114/rtv until both TMC114 and TMC125 are commercially available or the therapy is no longer of clinical benefit to the patient. Patients will receive an antiretroviral therapy consisting of TMC125 as the only non-nucleoside reverse transcriptase inhibitor (NNRTI), TMC114/rtv as the only protease inhibitor (PI) and an optimized background, which will be selected by the investigator according to the local standard of care, the patient's experience with previous therapies and most recent resistance testing. The most recent HIV-1 genotype-analysis system report results from the DUET trial will be made available. TMC125 will be dosed at 200 mg twice daily, administered orally as 2 tablets twice daily with food.TMC114/rtv will be dosed at 600/100 mg twice daily, administered orally as 2 tablets TMC114 and 1 capsule ritonavir twice daily with food.The optimized background will comprise of at least 1 approved ARV drug: 1 or more NRTI(s), with or without ENF. Administration will continue until both TMC114 and TMC125 are commercially available or therapy is no longer of clinical benefit to the patient.

Eligibility criteria: Inclusion Criteria:

* Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and completed at least 24 weeks of treatment
* Patient was virologically failing in a DUET trial.

Exclusion Criteria:

* Use of disallowed concomitant therapy
* Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table
* Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.

Primary outcomes:
measure: The Number of Participants Experiencing Adverse Events
timeFrame: 1 week to 180 weeks, with a median of 62 weeks
Secondary outcomes:
measure: The Percentage of Participants With Virologic Outcomes Over Time
timeFrame: Weeks 24, 48, and 96
measure: Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)
timeFrame: Baseline, Week 24, Week 48, and Week 96
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: Palm Springs
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Fort Laudersale
country: United States
state: Florida
city: Ft Lauderdale
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: N Miami Beach
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Camden
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Florencio Varela
country: Argentina
city: Neuquen
country: Argentina
city: Darlinghurst
country: Australia
city: Antwerpen
country: Belgium
city: Liege
country: Belgium
city: Curitiba
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Toronto
country: Canada
city: Providencia
country: Chile
city: Santiago
country: Chile
city: Bordeaux Cedex
country: France
city: Bordeaux N/A
country: France
city: Le Kremlin Bicetre
country: France
city: Lyon
country: France
city: Marseille Cedex 09
country: France
city: Paris Cedex 10
country: France
city: Paris Cedex 12
country: France
city: Paris Cedex 15
country: France
city: Paris, 75
country: France
city: Paris
country: France
city: Rennes
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Villejuif N/A
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Ciudad De Mexico
country: Mexico
city: Mex Ctity
country: Mexico
city: Panama
country: Panama
city: San Juan
country: Puerto Rico
city: Barcelona N/A
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Tibotec Pharmaceutical Limited
name: Tibotec Pharmaceuticals Clinical Trial
role: STUDY_DIRECTOR
References: