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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00146328 |
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 |
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 |
Enrollment: | 997 |
Study Start Date: | April 2001 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
Exclusion Criteria:
Female subjects who are of reproductive potential who:
Active use of any of the following:
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.
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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) |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Tipranavir |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |