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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00146328




Registration number
NCT00146328
Ethics application status
Date submitted
5/09/2005
Date registered
7/09/2005
Date last updated
6/03/2014

Titles & IDs
Public title
Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects
Scientific title
A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects
Secondary ID [1] 0 0
1182.17
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
Experimental: Group 1 - Patients With Varying Degrees of Tipranavir Treatment Experience

Experimental: Group 2 - Highly Tipranavir Treatment Experienced Patients

Experimental: Group 3 - Tipranavir Treatment Naive Patients
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin
Timepoint [1] 0 0
End of Trial (>288 weeks)
Primary outcome [2] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.
Timepoint [2] 0 0
End of Trial (>288 weeks)
Primary outcome [3] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets
Timepoint [3] 0 0
End of Trial (>288 weeks)
Primary outcome [4] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time
Timepoint [4] 0 0
End of Trial (>288 weeks)
Primary outcome [5] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium
Timepoint [5] 0 0
End of Trial (>288 weeks)
Primary outcome [6] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium
Timepoint [6] 0 0
End of Trial (>288 weeks)
Primary outcome [7] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium
Timepoint [7] 0 0
End of Trial (>288 weeks)
Primary outcome [8] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate
Timepoint [8] 0 0
End of Trial (>288 weeks)
Primary outcome [9] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide
Timepoint [9] 0 0
End of Trial (>288 weeks)
Primary outcome [10] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)
Timepoint [10] 0 0
End of Trial (>288 weeks)
Primary outcome [11] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)
Timepoint [11] 0 0
End of Trial (>288 weeks)
Primary outcome [12] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase
Timepoint [12] 0 0
End of Trial (>288 weeks)
Primary outcome [13] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase
Timepoint [13] 0 0
End of Trial (>288 weeks)
Primary outcome [14] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase
Timepoint [14] 0 0
End of Trial (>288 weeks)
Primary outcome [15] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase
Timepoint [15] 0 0
End of Trial (>288 weeks)
Primary outcome [16] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose
Timepoint [16] 0 0
End of Trial (>288 weeks)
Primary outcome [17] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total
Timepoint [17] 0 0
End of Trial (>288 weeks)
Primary outcome [18] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine
Timepoint [18] 0 0
End of Trial (>288 weeks)
Primary outcome [19] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total
Timepoint [19] 0 0
End of Trial (>288 weeks)
Primary outcome [20] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides
Timepoint [20] 0 0
End of Trial (>288 weeks)
Primary outcome [21] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid
Timepoint [21] 0 0
End of Trial (>288 weeks)
Primary outcome [22] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin
Timepoint [22] 0 0
End of Trial (>288 weeks)
Primary outcome [23] 0 0
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)
Timepoint [23] 0 0
End of Trial (>288 weeks)
Primary outcome [24] 0 0
Number of Patients With Adverse Events Leading to Death
Timepoint [24] 0 0
End of Trial (>288 weeks)
Secondary outcome [1] 0 0
Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)
Timepoint [1] 0 0
Baseline to 192-240 week time interval
Secondary outcome [2] 0 0
Change From Baseline in CD4 Cell Count (LOCF)
Timepoint [2] 0 0
Baseline to 192-240 week time interval

Eligibility
Key inclusion criteria
INCLUSION CRITERIA

1. Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
2. All subjects must have successfully completed participation in a combination tipranavir/ritonavir trial or have confirmed virologic failure in the 1182.12 or 1182.48 trials and are not able to obtain TPV by prescription. Successful completion of participation is defined as conclusion of required subject-weeks on assigned dosing (trial specific) and completion of required visits.
3. Male and female subjects 18 years and over.
4. Presence of Human Immunodeficiency Virus 1 (HIV-1) infection as documented by any licensed Enzyme Linked immunosorbent Assay (ELISA) test kit and confirmed by Western Blot, or HIV-1 culture, or HIV-1 antigen, or plasma HIV 1 Ribonucleic Acid (RNA) or a second antibody test by a method other than ELISA at any time prior to study entry.
5. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator).
6. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:

* Total Cholesterol =400 mg/dl (<Common Toxicity Criteria (CTC) Grade 2).
* Total Triglycerides =750 mg/dl (<Division of AIDS (DAIDS) Grade 2).
* Alanine aminotransferase (ALT) =3.0x upper limit of normal (ULN) and Aspartate aminotransferase (AST) =2.5x ULN (<DAIDS Grade 1).
* Any Grade Gamma Glutamyl transpeptidase(GGT) is acceptable.
* Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
* All other laboratory test values =DAIDS Grade 1.

EXCLUSION CRITERIA

1. Female subjects who are of reproductive potential who:

* Have a positive serum beta human chorionic gonadotropin (B HCG) at Screening/Enrollment Visit.
* Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms).
* Are breast-feeding.
2. Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use) which is considered by the investigator to be a significant impairment to health and to protocol adherence.
3. Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol.
4. History of any illness or drug allergy which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir/ritonavir to the subject.
5. Active use of any of the following:

* Investigational HIV-1 vaccines.
* Any new investigational antiretroviral agent that was not approved for use in the patients prior tipranavir trial.
* Medications excluded during the trial period (see Section 4.2).
* Herbal medications (e.g., St. John's Wort).
6. Active HIV-related or non HIV-related illness that may be negatively affected by use of tipranavir/ritonavir as determined by the investigator.

If a subject must temporarily discontinue tipranavir/ritonavir at the recommendation of the investigator (at the completion of the previous tipranavir trial), then the subject may enroll in 1182.17 once the clinical illness has resolved, and after approval from the Boehringer Ingelheim Clinical Monitor or Local Clinical Monitor.
7. Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values.
8. Hypersensitivity to tipranavir or ritonavir.
9. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
997
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
1182.17.401 St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
1182.17.402 Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [3] 0 0
1182.17.405 AIDS Research Initiative - DarlingHurst
Recruitment hospital [4] 0 0
1182.17.407 Holdsworth House General Practice - Darlinghurst
Recruitment hospital [5] 0 0
1182.17.408 407 Doctors Pty Ltd. - Darlinghurst
Recruitment hospital [6] 0 0
1182.17.403 Albion Street Clinic - Surry Hills
Recruitment hospital [7] 0 0
1182.17.404 Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- DarlingHurst
Recruitment postcode(s) [3] 0 0
- Surry Hills
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Argentina
State/province [30] 0 0
Capital Federal
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belgium
State/province [32] 0 0
Antwerpen
Country [33] 0 0
Belgium
State/province [33] 0 0
Bruxelles
Country [34] 0 0
Belgium
State/province [34] 0 0
Gent
Country [35] 0 0
Belgium
State/province [35] 0 0
Luxembourg
Country [36] 0 0
Brazil
State/province [36] 0 0
Canela - Salvador - BA
Country [37] 0 0
Brazil
State/province [37] 0 0
Cerqueira César, São Paulo - SP
Country [38] 0 0
Brazil
State/province [38] 0 0
Cidade Nova - Rio de Janeiro - RJ
Country [39] 0 0
Brazil
State/province [39] 0 0
Manguinhos - Rio de Janeiro - RJ
Country [40] 0 0
Brazil
State/province [40] 0 0
Mercês - Curitiba - PR
Country [41] 0 0
Brazil
State/province [41] 0 0
Nova Iguaçu - Rio de Janeiro - RJ
Country [42] 0 0
Brazil
State/province [42] 0 0
Sacoma - São Paulo - SP
Country [43] 0 0
Brazil
State/province [43] 0 0
São Paulo - SP
Country [44] 0 0
Brazil
State/province [44] 0 0
São Paulo, SP
Country [45] 0 0
Brazil
State/province [45] 0 0
Vila Mariana, Sao Paulo - SP
Country [46] 0 0
Canada
State/province [46] 0 0
British Columbia
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Denmark
State/province [49] 0 0
Aarhus N
Country [50] 0 0
Denmark
State/province [50] 0 0
Copenhagen Ø
Country [51] 0 0
Denmark
State/province [51] 0 0
Hvidovre
Country [52] 0 0
Denmark
State/province [52] 0 0
Odense
Country [53] 0 0
France
State/province [53] 0 0
Bordeaux cedex
Country [54] 0 0
France
State/province [54] 0 0
Caen cedex 5
Country [55] 0 0
France
State/province [55] 0 0
Clamart
Country [56] 0 0
France
State/province [56] 0 0
Lyon cedex 2
Country [57] 0 0
France
State/province [57] 0 0
Lyon cedex 3
Country [58] 0 0
France
State/province [58] 0 0
Marseille cedex 5
Country [59] 0 0
France
State/province [59] 0 0
Marseille cedex 9
Country [60] 0 0
France
State/province [60] 0 0
Nantes cedex 1
Country [61] 0 0
France
State/province [61] 0 0
Nice cedex 3
Country [62] 0 0
France
State/province [62] 0 0
Paris cedex 14
Country [63] 0 0
France
State/province [63] 0 0
Paris cedex 15
Country [64] 0 0
France
State/province [64] 0 0
Paris cedex 18
Country [65] 0 0
France
State/province [65] 0 0
Paris cedex 20
Country [66] 0 0
France
State/province [66] 0 0
Paris
Country [67] 0 0
France
State/province [67] 0 0
Rennes cedex 9
Country [68] 0 0
France
State/province [68] 0 0
Strasbourg cedex
Country [69] 0 0
France
State/province [69] 0 0
Toulon
Country [70] 0 0
France
State/province [70] 0 0
Vandoeuvre les Nancy
Country [71] 0 0
France
State/province [71] 0 0
Villejuif cedex
Country [72] 0 0
Germany
State/province [72] 0 0
Aachen
Country [73] 0 0
Germany
State/province [73] 0 0
Berlin
Country [74] 0 0
Germany
State/province [74] 0 0
Bonn
Country [75] 0 0
Germany
State/province [75] 0 0
Dortmund
Country [76] 0 0
Germany
State/province [76] 0 0
Düsseldorf
Country [77] 0 0
Germany
State/province [77] 0 0
Erlangen
Country [78] 0 0
Germany
State/province [78] 0 0
Essen
Country [79] 0 0
Germany
State/province [79] 0 0
Frankfurt/Main
Country [80] 0 0
Germany
State/province [80] 0 0
Freiburg/Breisgau
Country [81] 0 0
Germany
State/province [81] 0 0
Freiburg
Country [82] 0 0
Germany
State/province [82] 0 0
Hamburg
Country [83] 0 0
Germany
State/province [83] 0 0
Hannover
Country [84] 0 0
Germany
State/province [84] 0 0
Heidelberg
Country [85] 0 0
Germany
State/province [85] 0 0
Köln
Country [86] 0 0
Germany
State/province [86] 0 0
Mannheim
Country [87] 0 0
Germany
State/province [87] 0 0
München
Country [88] 0 0
Germany
State/province [88] 0 0
Osnabrück
Country [89] 0 0
Germany
State/province [89] 0 0
Stuttgart
Country [90] 0 0
Greece
State/province [90] 0 0
Athens
Country [91] 0 0
Greece
State/province [91] 0 0
Patras
Country [92] 0 0
Greece
State/province [92] 0 0
Thessaloniki
Country [93] 0 0
Italy
State/province [93] 0 0
Antella (fi)
Country [94] 0 0
Italy
State/province [94] 0 0
Busto Arsizio (va)
Country [95] 0 0
Italy
State/province [95] 0 0
Ferrara
Country [96] 0 0
Italy
State/province [96] 0 0
Genova
Country [97] 0 0
Italy
State/province [97] 0 0
Lecco
Country [98] 0 0
Italy
State/province [98] 0 0
Macerata
Country [99] 0 0
Italy
State/province [99] 0 0
Milano
Country [100] 0 0
Italy
State/province [100] 0 0
Modena
Country [101] 0 0
Italy
State/province [101] 0 0
Napoli
Country [102] 0 0
Italy
State/province [102] 0 0
Pavia
Country [103] 0 0
Italy
State/province [103] 0 0
Roma
Country [104] 0 0
Italy
State/province [104] 0 0
Torino
Country [105] 0 0
Mexico
State/province [105] 0 0
Col. La Raza, Mexico
Country [106] 0 0
Mexico
State/province [106] 0 0
Guadalajara
Country [107] 0 0
Mexico
State/province [107] 0 0
Monterrey, N.l., Mexico
Country [108] 0 0
Netherlands
State/province [108] 0 0
Amsterdam
Country [109] 0 0
Netherlands
State/province [109] 0 0
Groningen
Country [110] 0 0
Netherlands
State/province [110] 0 0
Nijmegen
Country [111] 0 0
Netherlands
State/province [111] 0 0
Rotterdam
Country [112] 0 0
Portugal
State/province [112] 0 0
Cascais
Country [113] 0 0
Spain
State/province [113] 0 0
Badalona
Country [114] 0 0
Spain
State/province [114] 0 0
Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Malaga
Country [117] 0 0
Spain
State/province [117] 0 0
Sevilla
Country [118] 0 0
Spain
State/province [118] 0 0
Valencia
Country [119] 0 0
Spain
State/province [119] 0 0
Vigo
Country [120] 0 0
Switzerland
State/province [120] 0 0
Basel
Country [121] 0 0
Switzerland
State/province [121] 0 0
Genève
Country [122] 0 0
Switzerland
State/province [122] 0 0
St. Gallen
Country [123] 0 0
Switzerland
State/province [123] 0 0
Zürich
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Brighton
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Liverpool
Country [126] 0 0
United Kingdom
State/province [126] 0 0
London
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Portsmouth

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00146328