- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00258557
TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients.
Study Overview
Detailed Description
This is a randomized, controlled, open-label trial to investigate the antiviral activity, tolerability and safety of TMC114/r) versus lpv/rtv in treatment-naive HIV-1 infected patients. Six hundred sixty treatment-naïve HIV-1 infected patients will be randomized in a 1:1 ratio to either 800/100 mg of TMC114/r once daily, or a total daily dose of 800/200 mg of lpv/rtv. All patients will take TMC114/r or lpv/rtv in combination with an NRTI background of Truvada (a combination pill of tenofovir and emtricitabine, "TDF/FTC"). The trial will consist of a screening period of approximately 14 to 28 days and a 96-week treatment period, followed by a 4-week follow-up period. The anti HIV-1 therapy initiated at baseline cannot be changed until the end of the treatment period. After the end of the treatment period (maximum of 96 weeks), patients will be followed for an additional 4 weeks to follow-up on any adverse events or laboratory abnormalities until resolution. Patients who fail either virologically or due to intolerance from the TMC114/r or lpv/rtv therapy, as judged by the investigator, or who meet one of the withdrawal criteria will be withdrawn from the trial and may have the opportunity to participate in the rollover phase of the trial.
The primary efficacy parameter is virologic response defined as a confirmed viral load < 50 copies/mL at Week 48 the objective of this study is to establish non-inferiority of TMC114/r versus lpv/rtv in terms of virologic response at Week 48 using a non-inferiority margin of 12%. To test this hypothesis, a two-sided 95% confidence interval (CI) of the difference in response rate between TMC114/r and lpv/rtv will be derived: If the lower bound of the CI exceeds -12%, non-inferiority will be concluded. Patients will take oral doses for up to 96 weeks of either 800/100mg of TMC114/r 1x/day or 800/200mg of lpv/rtv once daily, each in combination with TDF/FTC. (The 400/100 mg 2x/day dose of lpv/rtv will be used where the 1x/day use of lpv/rtv is not approved).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Buenos Aires, Argentina
-
Mar Del Plata N/A, Argentina
-
Neuquen, Argentina
-
-
-
-
-
Brisbane, Australia
-
Darlinghurst, Australia
-
Surry Hills, Australia
-
Westmead N/A, Australia
-
-
-
-
-
Wien, Austria
-
-
-
-
-
Brussels, Belgium
-
Gent, Belgium
-
Leuven, Belgium
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Canada
-
-
Ontario
-
Ottawa, Ontario, Canada
-
Toronto, Ontario, Canada
-
-
Quebec
-
Montreal, Quebec, Canada
-
-
-
-
-
Providencia, Chile
-
Santiago, Chile
-
-
-
-
-
Costa Rica, Costa Rica
-
San Jose, Costa Rica
-
-
-
-
-
Aalborg, Denmark
-
Copenhagen Ø, Denmark
-
Hvidovre, Denmark
-
-
-
-
-
Bobigny, France
-
Lyon, France
-
Nice, France
-
Orleans Cedex 2, France
-
Paris, France
-
Paris Cedex 12, France
-
-
-
-
-
Berlin, Germany
-
Erlangen, Germany
-
Freiburg, Germany
-
Hamburg, Germany
-
Köln, Germany
-
Mannheim, Germany
-
Munich, Germany
-
München, Germany
-
-
-
-
-
Athens, Greece
-
-
-
-
-
Guatemala, Guatemala
-
-
-
-
-
Sungai Buloh, Malaysia
-
-
-
-
-
Ciudad De Mexico, Mexico
-
Del Tlalpan, Mexico
-
Guadalajara N/A, Mexico
-
Mex Ctity, Mexico
-
-
-
-
-
Panama, Panama
-
-
-
-
-
San Juan, Puerto Rico
-
-
-
-
-
Kazan, Russian Federation
-
Krasnodar, Russian Federation
-
Moscow N/A, Russian Federation
-
Saint-Petersburg, Russian Federation
-
Sint Petersburg, Russian Federation
-
Smolensk, Russian Federation
-
St Petersburg, Russian Federation
-
Volgograd, Russian Federation
-
Voronezh, Russian Federation
-
-
-
-
-
Singapore, Singapore
-
-
-
-
-
Cape Town, South Africa
-
Dundee, South Africa
-
Johannesburg, South Africa
-
Pretoria, South Africa
-
-
-
-
-
Barcelona, Spain
-
Barcelona N/A, Spain
-
-
-
-
-
Zurich N/A, Switzerland
-
-
-
-
-
Taipei, Taiwan
-
Tiachung, Taiwan
-
-
-
-
-
Bangkok, Thailand
-
Chiang Mai, Thailand
-
Khon Kaen, Thailand
-
-
-
-
-
Brighton, United Kingdom
-
London, United Kingdom
-
-
-
-
Arizona
-
Phoenix, Arizona, United States
-
-
California
-
Beverly Hills, California, United States
-
Long Beach, California, United States
-
Los Angeles, California, United States
-
Sacramento, California, United States
-
San Francisco, California, United States
-
-
District of Columbia
-
Washington, District of Columbia, United States
-
-
Florida
-
Fort Lauderdale, Florida, United States
-
Jacksonville, Florida, United States
-
Miami, Florida, United States
-
Miami Beach, Florida, United States
-
Orlando, Florida, United States
-
Safety Harbor, Florida, United States
-
Tampa, Florida, United States
-
Vero Beach, Florida, United States
-
-
Maryland
-
Baltimore, Maryland, United States
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
-
Nevada
-
Las Vegas, Nevada, United States
-
-
New York
-
Brooklyn, New York, United States
-
-
North Carolina
-
Chapel Hill, North Carolina, United States
-
Winston Salem, North Carolina, United States
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
-
-
South Carolina
-
Columbia, South Carolina, United States
-
-
Texas
-
Houston, Texas, United States
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with documented HIV-1 infection
- Screening plasma HIV-1 RNA >= 5000 copies/mL
- Patients qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines
- Patients who can comply with the protocol requirements
- General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.
Exclusion Criteria:
- Presence of any currently active AIDS defining illness or receiving treatment for primary HIV infection
- Life expectancy of less than 6 months
- Previous or current use of antiretroviral medications (ARVs) for the treatment of HIV-infection or hepatitis B infection with anti-HIV activity
- Female -patients who are pregnant or breast-feeding, or are of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
- -patients with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading, or a calculated creatinine clearance (CLCr) < 70 mL/min
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 002
TMC-114/RTV two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max.
192 weeks
|
two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max.
192 weeks
|
Active Comparator: 001
LPV/RTV 400/100 mg twice daily or 800/200 mg daily depending on the country for max.
192 weeks
|
400/100 mg twice daily or 800/200 mg daily depending on the country for max.
192 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment
Time Frame: 192 weeks
|
192 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mills AM, Nelson M, Jayaweera D, Ruxrungtham K, Cassetti I, Girard PM, Workman C, Dierynck I, Sekar V, Abeele CV, Lavreys L. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009 Aug 24;23(13):1679-88. doi: 10.1097/QAD.0b013e32832d7350.
- Orkin C, DeJesus E, Khanlou H, Stoehr A, Supparatpinyo K, Lathouwers E, Lefebvre E, Opsomer M, Van de Casteele T, Tomaka F. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naive patients in the ARTEMIS trial. HIV Med. 2013 Jan;14(1):49-59. doi: 10.1111/j.1468-1293.2012.01060.x. Epub 2012 Oct 23.
Helpful Links
- Phase III randomized, controlled, open-label trial to investigate the antiviral activity, tolerability and safety of TMC114/r in treatment- naive HIV-1 infected patients.
- Phase III randomized, controlled, open-label trial to investigate the antiviral activity, tolerability and safety of TMC114/r in treatment- naive HIV-1 infected patients.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR002800
- TMC114-C211 (Other Identifier: Tibotec Pharmaceuticals, Ireland)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthNot yet recruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
CDC FoundationGilead SciencesUnknownHIV Preexposure Prophylaxis | HIV ChemoprophylaxisUnited States
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... and other collaboratorsRecruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Fenway Community Health; Tuberculosis...CompletedHIV/STI Risk | HIV/STI IncidenceUnited States, India
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
University of WashingtonNational Institute of Mental Health (NIMH)RecruitingHIV Prevention | HIV Preexposure Prophylaxis | ImplementationKenya
-
University of Maryland, BaltimoreWithdrawnHiv | Kidney Transplant | HIV Reservoir | CCR5United States
Clinical Trials on TMC-114/RTV
-
Modum BadCompletedComplex Post-Traumatic Stress DisorderNorway
-
Grace Lim, MD, MSCompletedPostpartum Depression | Pregnancy Related | Anxiety and DepressionUnited States
-
ORIC PharmaceuticalsCompleted
-
Fusion Pharma LLCData Matrix Solutions; OCT Rus, LLC; Skolkovo Innovation CenterUnknownLeukemia, Myelogenous, Chronic, BCR-ABL Positive | Chronic Myeloid LeukemiaRussian Federation
-
Placon TherapeuticsUnknownBreast Neoplasms | Prostatic Neoplasms | Pancreatic Neoplasms | Ovarian NeoplasmsUnited States
-
Avobis Bio, LLCAlimentiv Inc.RecruitingCrohn's Disease | Perianal FistulaUnited States
-
Tibotec Pharmaceuticals, IrelandApproved for marketingHIV InfectionsUnited States, Belgium, Germany, Taiwan, Spain, Switzerland, Mexico, Slovenia, Malaysia, Turkey, Canada, Netherlands, Denmark, Greece, Sweden, Russian Federation, Czech Republic, Puerto Rico, Thailand, Hungary, Luxembourg, Venezuela
-
Escalier Biosciences B.V.Innovaderm Research Inc.CompletedPsoriatic PlaqueUnited States, Canada