Clinical trial NCT00144105: A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
Official title: A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 562
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: Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to trial participation.
2. HIV-1 infected males or females \>= 18 years of age.
3. No previous ARV therapy.
4. Any CD4+ T lymphocyte count \< 500 cells / µl.
5. HIV-1 viral load \>= 5000 copies/mL at screening.
6. Screening laboratory values that indicate adequate baseline organ function.
7. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening

Exclusion criteria:

1. Female patients of child-bearing potential who:

   * have a positive serum pregnancy test at screening or during the study,
   * are breast feeding,
   * are planning to become pregnant
2. Use of investigational medications within 30 days before study entry or during the trial

Primary outcomes:
measure: The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.
Secondary outcomes:
measure: Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.
Other outcomes:
Locations:
city: BsAs
country: Argentina
facility: Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped
city: Buenos Aires
country: Argentina
facility: Hospital de Agudos Teodoro Alvarez
city: Haedo
country: Argentina
facility: Hospital Posadas
city: Darlinghurst
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincents Hospital;
state: New South Wales
city: Liverpool
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: New South Wales
city: Surry Hills
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: New South Wales
city: Carlton
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: South Yarra
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: Victoria
city: Nassau
country: Bahamas
facility: Princess Margaret Hospital
city: Campinas - Sp
country: Brazil
facility: Unidade de Pesquisa Clínica (UPC) - AIDS
city: Curitiba - PR
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: Manguinhos - Rio de Janeiro - RJ
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: Mooca / São Paulo
country: Brazil
facility: Instituto de Crianca / Hospital das Clínicas-FMUSP
city: Nova Iguaçu - RJ
country: Brazil
facility: Hospital Geral de Nova Iguaçu - Ministério da Saúde
city: Rio de Janeiro - RJ
country: Brazil
facility: Universidade Federal do Rio de Janeiro
city: Sacoma - São Paulo
country: Brazil
facility: Hospital Dia
city: Salvador - BA
country: Brazil
facility: Universidade Federal da Bahia-Unidade Docente Assistencial d
city: Santos - Sp
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: São Paulo - Sp
country: Brazil
facility: Hospital do Servidor Público Estadual de São Paulo
city: São Paulo - SP
country: Brazil
facility: I.I. Emilio Ribas - Moléstias Infecciosas
city: São Paulo - SP
country: Brazil
facility: Instituto de Infectologia Emílio Ribas
city: São Paulo - Sp
country: Brazil
facility: UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
city: Vila Mariana - Sao Paulo
country: Brazil
facility: Centro de Referência e Treinamento - DST/AIDS
city: Vancouver
country: Canada
facility: Downtown Infectious Diseases Clinic
state: British Columbia
city: Winnipeg
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Riverside Campus
state: Ontario
city: Toronto
country: Canada
facility: Canadian Immunodeficiency Research Collaborative Inc.
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Woman's College Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Whitby
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Monteal
country: Canada
facility: Montreal General Hospital - McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Montreal Chest Institute, McGill University Health Centre
state: Quebec
city: Bogotá
country: Colombia
facility: Boehringer Ingelheim Investigational Site
city: Bondy cedex
country: France
facility: Hôpital Jean Verdier
city: Dijon cedex
country: France
facility: Hôpital Bocage
city: La Tronche
country: France
facility: Hôpital Albert Michallon
city: Lyon
country: France
facility: Hop Hôtel Dieu
city: Montpellier cedex 5
country: France
facility: Hôpital Gui de Chauliac
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Saint Etienne
country: France
facility: Hôpital Bellevue
city: Berlin
country: Germany
facility: Epimed GmbH
city: Bochum
country: Germany
facility: Klinikum der Ruhr-Universität Bochum
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: ifi Studien und Projekte GbR
city: Köln
country: Germany
facility: Universitätsklinik Köln
city: München
country: Germany
facility: Medizinische Poliklinik
city: Col. Morelos, Monterrey, N. L.
country: Mexico
facility: Hospital de Especialidades no. 25
city: Col. Villaseñor, Guadalajara, Jal.
country: Mexico
facility: Hospital Juan I. Menchaca IMSS
city: Mexico
country: Mexico
facility: Hospital Lopez Mateos
city: Chorzow
country: Poland
facility: Centre for AIDS Diagnostics and Therapy
city: Szczecin
country: Poland
facility: Medical Academy of Szczecin
city: Warsaw
country: Poland
facility: Hospital for Infectious Diseases
city: Wroclaw
country: Poland
facility: Department of Infectious Diseases
city: Bucharest
country: Romania
facility: Matei Bals Institute of Infectious Diseases
city: Bucharest
country: Romania
facility: Victor Babes Clincial Hospital
city: Moscow
country: Russian Federation
facility: Russian Federal Scientific
city: St. Petersburg
country: Russian Federation
facility: City Hospital St Petersburg
city: Badalona
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial
city: Hospitalet de Llobregat (Barcelona)
country: Spain
facility: Ciutat Sanitaria Universitaria de Bellvitge
city: Madrid
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: Hospital 12 de octubre
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Málaga
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Boehringer Ingelheim Investigational Site
city: Sevilla
country: Spain
facility: Hospital Universitario Vírgen del Rocío
city: Terrassa
country: Spain
facility: Hospital Mútua de Terrasa
city: Bangkok
country: Thailand
facility: Ramathibodhi Hospital
city: Pathumwan, Bangkok
country: Thailand
facility: King Chulalonkorn Hospital
city: Edinburgh
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: North Middlesex Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
name: Boehringer Ingelheim Study Coordinator
References: