Treatment with three-class (NRTI, NNRTI, and PI) experienced HIV positive patients with HCV or HBV co-infection, with a minimum of 3-months duration for each class and have documented resistance to more than one PI. They must be TPV naïve, have at least two available active ARV drugs to construct a background regimen. MedDRA version: 8.1 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Interventions
Trade Name: APTIVUS 250 mg soft capsules.
Pharmaceutical Form: Capsule, soft
Trade Name: Norvir 100 mg soft capsules
Pharmaceutical Form: Capsule, soft
Sponsors
BOEHRINGER-INGELHEIM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected males or females =18 years of age. 2. Three-class (NRTI, NNRTI, and PI) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI (on the screening resistance testing). 3. Chronic hepatitis C Virus infection demonstrated by HCV-RNA positivity or, Chronic hepatitis B infection demonstrated by anti-HBc-IgG Antibody and HB Surface Antigen positivity. 4. Patients must have at least one of the following permutations of active ARV medications available and must be willing to use them in the OBR for trial inclusion: - To genotypically active RTIs defined as two drugs that are reported as sensitive in the genotype report. - One genotypically active RTI reported as sensitive in the genotype report and Enfuvirtide (ENF) if not used previously. - One genotypically active RTI reported as sensitive in the genotype report and an investigational ARV drug that is offered in an expanded access program (if allowed by local regulatory authorities). - An investigational ARV drug that is offered in an expanded access program (if allowed by local regulatory authorities) and Enfuvirtide (ENF) if not used previously. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior tipranavir use 2. ARV medication naïve. 3. Genotypic resistance to TPV (defined as a TPV mutation score >7). 4. Decompensated liver disease, including presence or history of ascites, variceal bleeding, or hepatic encephalopathy or having ever been diagnosed as having hepatic insufficiency of Child Pugh class B or C. 5. Use of immunomodulatory drugs (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2) or antineoplastic agents within 30 days before study entry or during the trial. 6. Anticipated need for any interferon-based regimen in the 48 weeks following the study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the safety and efficacy of TPV/r (500 mg/200 mg BID) in ARV therapy experienced HIV-1 infected patients co-infected with HCV or HBV in the presence of an NRTI-based, resistance-driven optimized background regimen. ;Secondary Objective: The objective of the TDM pilot evaluation is to determine the potential utility of therapeutic drug monitoring in the use of TPV/r in co-infected patients. ;Primary end point(s): The primary endpoint is treatment response at Week 48. Treatment response is a confirmed virologic response, defined as a viral load <50 copies/mL at two consecutive measurements at least 5 days apart, without death, premature discontinuation of the study drug or loss to follow up, or introduction of a new antiretroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug. Occurrence of dose-limiting hepatotoxicity during the study. Dose-limiting hepatotoxicity is defined as Grade 4 ALT or AST elevation confirmed in 48h or any evocative symptoms or signs of hepatitis, if it not clearly attributable to another cause. | — |
Countries
France, Germany, Italy, Portugal, Spain
Outcome results
None listed