Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00146328
  Purpose

The objective of this study is to determine the long term safety and tolerability of multiple oral d oses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development d ose (500 mg TPV/200 mg RTV BID) when administered with other antiretroviral medications.


Condition Intervention Phase
HIV Infections
Drug: long term safety
Phase II

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir Tipranavir
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
Official Title: A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint will be an assessment of safety (with preliminary data set evaluations every 48 weeks or as needed). Safety parameters will include hematology, chemistry, liver functions and lipid levels. All AEs will be monitored. [ Time Frame: open ended until the study drug is available by prescription in the last OPU participating in the trial ]

Secondary Outcome Measures:
  • At each follow-up visit, secondary endpoints will be the following: Assessment of CD4 count Assessment of HIV-1 quantitative RNA Changes in antiretroviral therapy a. Same medications with different dosages b. Different medications [ Time Frame: open ended until the study drug is available by prescription in the last OPU participating in the trial ]

Enrollment: 997
Study Start Date: April 2001
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 TPV/RTV trial or have confirmed virologic failure in the 1182.12 or 1182.48 trial Successful completion of participation is defined as conclusion of required subject weeks on assigned dosing (trial specific) and completion of required visits.
  3. Presence of HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western Blot, or HIV-1 culture, or HIV-1 antigen, or plasma HIV 1 RNA or a second antibody test by a method other than ELISA at any time prior to study entry.
  4. Adherence to previous TPV/RTV dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator).
  5. 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 (<CTC Grade 2).
    • Total Triglycerides <750 mg/dl (<DAIDS Grade 2).
    • ALT <3.0x ULN and AST <2.5x ULN (<DAIDS Grade 1).
    • Any Grade GGT is acceptable.
    • Any Grade creatinine kinase is acceptable as long as there is no concurrent my opathy.
    • All other laboratory test values <DAIDS Grade 1.

Exclusion Criteria:

  1. Female subjects who are of reproductive potential who:

    • Have a positive serum B HCG at Screening/Enrollment Visit.
    • Are not willing to use a reliable method of barrier contraception (such as dia phragm 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 TPV/RTV 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 TPV/RTV as determined by the investigator.

    - If a subject must temporarily discontinue TPV/RTV at the recommendation of the investigator (at the completion of the previous TPV trial), then the subject may enroll in 1182.17 once the clinical illness has resolved, and after approval from the BI 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 TPV or RTV.
  9. Voluntary discontinuation of antiretroviral therapy (including TPV/RTV) for more than seven days from completion of previous TPV trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146328

  Show 233 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1182.17
Study First Received: September 5, 2005
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00146328  
Health Authority: Australia: Responsilble Ethics Committee;   Belgium: Federal Agency for Medicines and Health Products;   United States: Food and Drug Administration;   Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología)

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Tipranavir

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009