Clinical trial NCT00245739: TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
Official title: Early Access of TMC114 in Combination With Low-dose Ritonavir (TMC/r)) and Other Antiretrovirals (ARVs) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to no Treatment Options.
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: HIV Infections
Keywords: HIV infections
HIV-1
TMC114
Early access
Highly antiretroviral treatment experienced patients
Anti-retroviral agents
Lead sponsor: Tibotec Pharmaceuticals, Ireland
Sponsor class: INDUSTRY
First posted: 2005-10-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals

Detailed description: This is a program to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients, who have failed multiple antiretroviral (ARV) regimens and who are ineligible for participation in any other Tibotec-sponsored HIV trial. Patients need to be at least 3 class experienced (PIs, NRTIs, NtRTIs, NNRTIs or FI), to have previously received 2 different protease inhibitor-based regimens and to not be virologically suppressed on their current regimen. Patients eligible for any other Tibotec sponsored HIV trial but located more than 100 kilometers away from a study site, will be considered eligible for this early access program.

This program will be conducted as an open-label, non-randomized treatment study. Once treatment with TMC114/r in combination with other antiretrovirals (ARVs) has been initiated (baseline visit), patients will follow the recommended visit schedule based on routine clinical care. No other protease inhibitor combinations other than TMC114/r are to be used in this study, except atazanavir (ATV) and indinavir (IDV) may be allowed. Trial medication will be dispensed every 8 weeks. Treatment with TMC114/r will be continued until treatment-limiting toxicity, loss to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC114 development or when TMC114 has become commercially available.

Selected safety and tolerability data, including adverse events will be collected throughout the study. A urine pregnancy test will be repeated at baseline for female patients if more than 4 weeks have passed since the test at screening, and urine pregnancy tests will be performed at all other visits. In addition, data on CD4 count and viral load will be collected over the treatment period according to local standard of care practice, in order to ensure that patients continue to benefit from treatment with TMC114/r. A final/withdrawal visit as well as a post-trial treatment follow-up contact (4 weeks after the final/withdrawal visit) will be performed. Patients will take oral doses of 600 mg of TMC114 twice daily in combination with 100 mg of ritonavir twice daily, in combination with other antiretrovirals.

Eligibility criteria: Inclusion Criteria:

* Patient with documented HIV-1 infection
* has limited or no treatment options due to virological failure or intolerance to multiple antiretroviral regimens
* is at least 3 class experienced and has previously received 2 different protease inhibitor-based regimens
* has a CD4 cell count \<= 200 cells/mm3
* is not achieving adequate virologic suppression on his/her current regimen and is at risk of clinical or immunologic progression.

Exclusion Criteria:

* Patient has primary HIV-1 infection (unless documented resistance to all currently approved protease inhibitors participated or is currently participating in a trial with TMC114
* Patient used investigational medication within the last 30 days (except for abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations, and tipranavir)
* Patient suffers from any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or has evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels, or has grade 3 or 4 laboratory abnormalities as defined by National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) grading scheme
* Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
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state: Alabama
city: Birmingham
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city: Mesa
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state: Arizona
city: Phoenix
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city: Tucson
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city: Vancouver
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city: Prague
country: Czech Republic
city: Aalborg
country: Denmark
city: Aarhus
country: Denmark
city: Copenhagen
country: Denmark
city: Hvidovre N/A
country: Denmark
city: Odense N/A
country: Denmark
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Bremen
country: Germany
city: Chemnitz
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Duesseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Gießen
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Koblenz
country: Germany
city: Konstanz
country: Germany
city: Köln
country: Germany
city: Kÿln
country: Germany
city: Leipzig
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Munich
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Nürnberg
country: Germany
city: Osnabrück
country: Germany
city: Regensburg
country: Germany
city: Saarbrücken
country: Germany
city: Salzgitter
country: Germany
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country: Germany
city: Wuppertal
country: Germany
city: Würzburg
country: Germany
city: Athens
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country: Greece
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country: Greece
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country: Hungary
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country: Netherlands
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country: Puerto Rico
city: Rio Piedras Pr
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Ekaterinbourg
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk Region
country: Russian Federation
city: Rostov-Na-Donu
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Tver
country: Russian Federation
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country: Russian Federation
city: Voronezh
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country: Slovenia
city: Alicante
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country: Spain
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country: Spain
city: Calella (Barcelona)
country: Spain
city: Castellon
country: Spain
city: Cordoba
country: Spain
city: Cuenca
country: Spain
city: Donostia Guipuzcoa
country: Spain
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country: Spain
city: Elche
country: Spain
city: Figueres
country: Spain
city: Fuenlabrada
country: Spain
city: Gijon Asturias
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Guadalajara
country: Spain
city: Huelva N/A
country: Spain
city: Huelva
country: Spain
city: Huesca
country: Spain
city: Ibiza
country: Spain
city: Jérez
country: Spain
city: La Coruna
country: Spain
city: La Laguna
country: Spain
city: Las Palmas De Gran Canaria
country: Spain
city: Leon N/A
country: Spain
city: Lleida
country: Spain
city: Logrono
country: Spain
city: Madrid N/A
country: Spain
city: Madrid
country: Spain
city: Mahon Menorca
country: Spain
city: Malaga N/A
country: Spain
city: Malaga
country: Spain
city: Manresa
country: Spain
city: Murcia N/A
country: Spain
city: Murcia
country: Spain
city: Oviedo
country: Spain
city: Palma De Mallorca Illes Balear
country: Spain
city: Palma De Mallorca
country: Spain
city: Pamplona N/A
country: Spain
city: Puerto Real
country: Spain
city: Sabadell
country: Spain
city: Salamanca
country: Spain
city: Santander N/A
country: Spain
city: Santiago De Compostela
country: Spain
city: Sevilla N/A
country: Spain
city: Sevilla
country: Spain
city: Sta Cruz De Tenerife
country: Spain
city: Tarragona N/A
country: Spain
city: Tarragona
country: Spain
city: Terrassa
country: Spain
city: Valencia N/A
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Vic
country: Spain
city: Vigo
country: Spain
city: Villafranca Del Penedes
country: Spain
city: Vitoria-Gasteiz
country: Spain
city: Vizcaya N/A
country: Spain
city: Zamora N/A
country: Spain
city: Zaragoza
country: Spain
city: Göteborg N/A
country: Sweden
city: Göteborg
country: Sweden
city: Linköping
country: Sweden
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Aarau
country: Switzerland
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Bruderholz
country: Switzerland
city: Chur
country: Switzerland
city: Genève
country: Switzerland
city: Lausanne
country: Switzerland
city: Lugano N/A
country: Switzerland
city: St Gallen
country: Switzerland
city: Zurich N/A
country: Switzerland
city: Zurich Zh
country: Switzerland
city: Kaohsiung County
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Bangkok
country: Thailand
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Caracas
country: Venezuela
Study officials:
affiliation: Tibotec Pharmaceutical Limited
name: Tibotec Pharmaceuticals Clinical Trial
role: STUDY_DIRECTOR
References: