Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00144105




Registration number
NCT00144105
Ethics application status
Date submitted
2/09/2005
Date registered
5/09/2005
Date last updated
1/11/2013

Titles & IDs
Public title
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.
Scientific 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
Secondary ID [1] 0 0
1182.33
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TPV500mg/RTV200mgBID
Treatment: Drugs - TPV500mg/RTV100mgBID
Treatment: Drugs - LPV400mg/RTV100mgBID

Treatment: Drugs: TPV500mg/RTV200mgBID


Treatment: Drugs: TPV500mg/RTV100mgBID


Treatment: Drugs: LPV400mg/RTV100mgBID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
562
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
St Vincents Hospital; - Darlinghurst
Recruitment hospital [3] 0 0
Boehringer Ingelheim Investigational Site - Liverpool
Recruitment hospital [4] 0 0
Boehringer Ingelheim Investigational Site - Surry Hills
Recruitment hospital [5] 0 0
Boehringer Ingelheim Investigational Site - Carlton
Recruitment hospital [6] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Boehringer Ingelheim Investigational Site - South Yarra
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Surry Hills
Recruitment postcode(s) [4] 0 0
- Carlton
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- South Yarra
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
BsAs
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Haedo
Country [4] 0 0
Bahamas
State/province [4] 0 0
Nassau
Country [5] 0 0
Brazil
State/province [5] 0 0
Campinas - Sp
Country [6] 0 0
Brazil
State/province [6] 0 0
Curitiba - PR
Country [7] 0 0
Brazil
State/province [7] 0 0
Manguinhos - Rio de Janeiro - RJ
Country [8] 0 0
Brazil
State/province [8] 0 0
Mooca / São Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Nova Iguaçu - RJ
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio de Janeiro - RJ
Country [11] 0 0
Brazil
State/province [11] 0 0
Sacoma - São Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
Salvador - BA
Country [13] 0 0
Brazil
State/province [13] 0 0
Santos - Sp
Country [14] 0 0
Brazil
State/province [14] 0 0
São Paulo - Sp
Country [15] 0 0
Brazil
State/province [15] 0 0
São Paulo - SP
Country [16] 0 0
Brazil
State/province [16] 0 0
Vila Mariana - Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
Manitoba
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Colombia
State/province [21] 0 0
Bogotá
Country [22] 0 0
France
State/province [22] 0 0
Bondy cedex
Country [23] 0 0
France
State/province [23] 0 0
Dijon cedex
Country [24] 0 0
France
State/province [24] 0 0
La Tronche
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
France
State/province [26] 0 0
Montpellier cedex 5
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Saint Etienne
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Bochum
Country [31] 0 0
Germany
State/province [31] 0 0
Düsseldorf
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
State/province [34] 0 0
Köln
Country [35] 0 0
Germany
State/province [35] 0 0
München
Country [36] 0 0
Mexico
State/province [36] 0 0
Col. Morelos, Monterrey, N. L.
Country [37] 0 0
Mexico
State/province [37] 0 0
Col. Villaseñor, Guadalajara, Jal.
Country [38] 0 0
Mexico
State/province [38] 0 0
Mexico
Country [39] 0 0
Poland
State/province [39] 0 0
Chorzow
Country [40] 0 0
Poland
State/province [40] 0 0
Szczecin
Country [41] 0 0
Poland
State/province [41] 0 0
Warsaw
Country [42] 0 0
Poland
State/province [42] 0 0
Wroclaw
Country [43] 0 0
Romania
State/province [43] 0 0
Bucharest
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Moscow
Country [45] 0 0
Russian Federation
State/province [45] 0 0
St. Petersburg
Country [46] 0 0
Spain
State/province [46] 0 0
Badalona
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Hospitalet de Llobregat (Barcelona)
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
Spain
State/province [50] 0 0
Málaga
Country [51] 0 0
Spain
State/province [51] 0 0
Santa Cruz de Tenerife
Country [52] 0 0
Spain
State/province [52] 0 0
Sevilla
Country [53] 0 0
Spain
State/province [53] 0 0
Terrassa
Country [54] 0 0
Thailand
State/province [54] 0 0
Bangkok
Country [55] 0 0
Thailand
State/province [55] 0 0
Pathumwan, Bangkok
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Edinburgh
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00144105
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim Study Coordinator
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00144105