HIV InfectionsPhase 2NCT00144105
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.
A Phase 2 study testing TPV500mg/RTV200mgBID, TPV500mg/RTV100mgBID and LPV400mg/RTV100mgBID in people with HIV Infections, run by Boehringer Ingelheim at 81 sites in 15 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- TPV500mg/RTV200mgBID, TPV500mg/RTV100mgBID and LPV400mg/RTV100mgBID
- How many people
- 562 participants
- Where
- 81 sitesin 15 countries
- Study dates
- Feb 2004to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to trial participation.
- HIV-1 infected males or females >= 18 years of age.
- No previous ARV therapy.
- Any CD4+ T lymphocyte count < 500 cells / µl.
- HIV-1 viral load >= 5000 copies/mL at screening.
- Screening laboratory values that indicate adequate baseline organ function.
- 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
Who cannot join
- 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
- Use of investigational medications within 30 days before study entry or during the trial
Trial locations and contacts
81 sites in 15 countries.
81 sites in 15 countries
Brazil14 sites
Unidade de Pesquisa Clínica (UPC) - AIDS
Campinas - Sp
Boehringer Ingelheim Investigational Site
Curitiba - PR
Boehringer Ingelheim Investigational Site
Manguinhos - Rio de Janeiro - RJ
Instituto de Crianca / Hospital das Clínicas-FMUSP
Mooca / São Paulo
Hospital Geral de Nova Iguaçu - Ministério da Saúde
Nova Iguaçu - RJ
Universidade Federal do Rio de Janeiro
Rio de Janeiro - RJ
Hospital Dia
Sacoma - São Paulo
Universidade Federal da Bahia-Unidade Docente Assistencial d
Salvador - BA
Boehringer Ingelheim Investigational Site
Santos - Sp
Hospital do Servidor Público Estadual de São Paulo
São Paulo - Sp
UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
São Paulo - Sp
I.I. Emilio Ribas - Moléstias Infecciosas
São Paulo - SP
Instituto de Infectologia Emílio Ribas
São Paulo - SP
Centro de Referência e Treinamento - DST/AIDS
Vila Mariana - Sao Paulo
Canada12 sites
McMaster University Medical Centre
Hamilton, Ontario
Montreal General Hospital - McGill University Health Centre
Monteal, Quebec
Boehringer Ingelheim Investigational Site
Montreal, Quebec
Montreal Chest Institute, McGill University Health Centre
Montreal, Quebec
The Ottawa Hospital Riverside Campus
Ottawa, Ontario
Canadian Immunodeficiency Research Collaborative Inc.
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Sunnybrook & Woman's College Health Science Centre
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Downtown Infectious Diseases Clinic
Vancouver, British Columbia
Boehringer Ingelheim Investigational Site
Whitby, Ontario
Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba
Spain11 sites
Boehringer Ingelheim Investigational Site
Badalona
Boehringer Ingelheim Investigational Site
Barcelona
Hospital Clínico y Provincial
Barcelona
Ciutat Sanitaria Universitaria de Bellvitge
Hospitalet de Llobregat (Barcelona)
Boehringer Ingelheim Investigational Site
Madrid
Hospital 12 de octubre
Madrid
Hospital Ramón y Cajal
Madrid
Boehringer Ingelheim Investigational Site
Málaga
Boehringer Ingelheim Investigational Site
Santa Cruz de Tenerife
Hospital Universitario Vírgen del Rocío
Seville
Hospital Mútua de Terrasa
Terrassa
Germany8 sites
Epimed GmbH
Berlin
Klinikum der Ruhr-Universität Bochum
Bochum
Universitätsklinik Köln
Cologne
Boehringer Ingelheim Investigational Site
Düsseldorf
Universitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinikum Essen
Essen
ifi Studien und Projekte GbR
Hamburg
Medizinische Poliklinik
München
Australia7 sites
Boehringer Ingelheim Investigational Site
Carlton, Victoria
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
St Vincents Hospital;
Darlinghurst, New South Wales
Boehringer Ingelheim Investigational Site
Liverpool, New South Wales
Alfred Hospital
Melbourne, Victoria
Boehringer Ingelheim Investigational Site
South Yarra, Victoria
Boehringer Ingelheim Investigational Site
Surry Hills, New South Wales
France7 sites
Hôpital Jean Verdier
Bondy
Hôpital Bocage
Dijon
Hôpital Albert Michallon
La Tronche
Hop Hôtel Dieu
Lyon
Hôpital Gui de Chauliac
Montpellier
Hôpital Saint Antoine
Paris
Hôpital Bellevue
Saint-Etienne
Argentina4 sites
Boehringer Ingelheim Investigational Site
BsAs
Fundacion Huesped
Buenos Aires
Hospital de Agudos Teodoro Alvarez
Buenos Aires
Hospital Posadas
Haedo
Poland4 sites
Centre for AIDS Diagnostics and Therapy
Chorzów
Medical Academy of Szczecin
Szczecin
Hospital for Infectious Diseases
Warsaw
Department of Infectious Diseases
Wroclaw
Mexico3 sites
Hospital de Especialidades no. 25
Col. Morelos, Monterrey, N. L.
Hospital Juan I. Menchaca IMSS
Col. Villaseñor, Guadalajara, Jal.
Hospital Lopez Mateos
México
United Kingdom3 sites
Boehringer Ingelheim Investigational Site
Edinburgh
North Middlesex Hospital
London
Royal Free Hospital
London
Romania2 sites
Matei Bals Institute of Infectious Diseases
Bucharest
Victor Babes Clincial Hospital
Bucharest
Russia2 sites
Russian Federal Scientific
Moscow
City Hospital St Petersburg
Saint Petersburg
Thailand2 sites
Ramathibodhi Hospital
Bangkok
King Chulalonkorn Hospital
Pathumwan, Bangkok
The Bahamas1 site
Princess Margaret Hospital
Nassau
About this study
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
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
- Conditions
- HIV Infections
- Being tested
- TPV500mg/RTV200mgBID, TPV500mg/RTV100mgBID, LPV400mg/RTV100mgBID
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPV500mg/RTV200mgBIDDrug
TPV500mg/RTV100mgBIDDrug
LPV400mg/RTV100mgBIDDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144105
- Sponsor's protocol ID
- 1182.33
- Status last verified
- Oct 2013
- First submitted
- 2 Sep 2005
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00144105
- Acronym / sponsor ID
- 1182.33
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Nov 2006 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent prior to trial participation.
- HIV-1 infected males or females >= 18 years of age.
- No previous ARV therapy.
- Any CD4+ T lymphocyte count < 500 cells / µl.
- HIV-1 viral load >= 5000 copies/mL at screening.
Key exclusion criteria (5 listed)
- Female patients of child-bearing potential who:
- Use of investigational medications within 30 days before study entry or during the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPV500mg/RTV200mgBID | Drug | – |
| TPV500mg/RTV100mgBID | Drug | – |
| LPV400mg/RTV100mgBID | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator
81 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPV500mg/RTV200mgBID, TPV500mg/RTV100mgBID and LPV400mg/RTV100mgBID in people with HIV Infections, run by Boehringer Ingelheim at 81 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in Brazil, Canada, Spain, Germany, Australia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.