Status:
COMPLETED
3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced pati...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signed informed consent prior to trial participation.
- Human immunodeficiency virus 1 (HIV-1) infected males or females \> 18 years of age.
- At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
- Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
- HIV-1 viral load ≥1000 copies/mL at screening.
- Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.
- Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".
- Acceptable screening laboratory values that indicate adequate baseline organ function.
- Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).
- Further inclusion criteria apply.
- Exclusion criteria:
- ARV medication naïve.
- Only one or no available ARV medications as determined by genotypic resistance testing.
- Female subjects who:
- have a positive serum pregnancy test at screening or during the study;
- are breast feeding;
- are planning to become pregnant;
- are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).
- Any active opportunistic infection within 60 days before study entry.
- Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \> Grade 1.
- Prior tipranavir use.
- Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
- Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
- Further exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
March 29 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00275444
Start Date
March 29 2002
Last Update
December 1 2023
Active Locations (62)
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1
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
2
Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
3
Living Hope Clinical Trials, Inc.
Long Beach, California, United States
4
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States