Safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot evaluation of therapeutic drug monitoring (TDM). An open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy

BOEHRINGER-INGELHEIM0 个研究点目标入组 200 人开始时间: 2007年1月25日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

BOEHRINGER-INGELHEIM