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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Drugs - Tipranavir

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


Treatment: Drugs: Tipranavir


Intervention code [1] 0 0
Treatment: Drugs
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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. - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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) - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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) - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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 - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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) - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Timepoint [23] 0 0
End of Trial (>288 weeks)
Primary outcome [24] 0 0
Number of Patients With Adverse Events Leading to Death - NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
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) - Change from baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) viral load with 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) - Change from baseline in CD4 cell count with last observation carried forward(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
Gender
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/Phase 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
State/province [2] 0 0
California
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Connecticut
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District of Columbia
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United States of America
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Maine
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Mexico
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New York
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North Carolina
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Ohio
Country [22] 0 0
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Capital Federal
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Gent
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Luxembourg
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Canela - Salvador - BA
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Brazil
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Cerqueira César, São Paulo - SP
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Brazil
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Cidade Nova - Rio de Janeiro - RJ
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Brazil
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Manguinhos - Rio de Janeiro - RJ
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Brazil
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Mercês - Curitiba - PR
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Nova Iguaçu - Rio de Janeiro - RJ
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Sacoma - São Paulo - SP
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São Paulo - SP
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São Paulo, SP
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Vila Mariana, Sao Paulo - SP
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Marseille cedex 5
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Marseille cedex 9
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Nantes cedex 1
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Nice cedex 3
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Paris cedex 14
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Rennes cedex 9
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Strasbourg cedex
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Toulon
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Vandoeuvre les Nancy
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Bonn
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Dortmund
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Düsseldorf
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Erlangen
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Essen
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Germany
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Frankfurt/Main
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Freiburg/Breisgau
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Freiburg
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Hamburg
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Hannover
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Heidelberg
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Köln
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Mannheim
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München
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Osnabrück
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Stuttgart
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Greece
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Athens
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Greece
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Patras
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Greece
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Thessaloniki
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Italy
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Antella (fi)
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Italy
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Busto Arsizio (va)
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Lecco
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Italy
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Macerata
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Modena
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Napoli
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Italy
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Pavia
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Italy
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Roma
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Italy
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Torino
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Mexico
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Col. La Raza, Mexico
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Mexico
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Guadalajara
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Mexico
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Monterrey, N.l., Mexico
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Netherlands
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Amsterdam
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Groningen
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Portugal
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Cascais
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Vigo
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Switzerland
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Basel
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Switzerland
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Genève
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Switzerland
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St. Gallen
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Switzerland
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Zürich
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United Kingdom
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Brighton
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United Kingdom
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Liverpool
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United Kingdom
State/province [126] 0 0
London
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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
The objective of this study is to determine the long term safety and tolerability of multiple
oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the
development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other
antiretroviral medications.
Trial website
https://clinicaltrials.gov/show/NCT00146328
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

Summary results
Other publications