Antiretroviral - Naive HIV-1 Infected Adults and Antiretroviral Experienced HIV-1 Infected Adults MedDRA version: 9.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV
Conditions
Interventions
Trade Name: Telzir 700mg film - coated tablets
Pharmaceutical Form: Film-coated tablet
CAS Number: 226700-81-8
Other descriptive name: Fosamprevanir calcium
Concentration unit: mg milligram(s)
Concen
Sponsors
Mater Misericordiae University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Subject is =18 years of age. 2. Subject can be both antiretroviral-naïve and experienced. 3. Subject is willing and able to understand and provide written informed consent prior to participation in this study. 4. Documented HCV co-infection (PCR positive) 5. Documented HIV infection by HIV antibody 6. A female is eligible to enter and participate in the study if she is of: 7. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or, 8. Child-bearing potential, has a negative pregnancy test (serum ß-HCG) at screen and agrees to an acceptable barrier and/or hormonal method of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician): Sterilization (female subject or male partner of female subject). ALL SUBJECTS PARTICIPATING IN THE STUDY SHOULD BE COUNSELLED ON THE PRACTICE OF SAFER SEX Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1. Subject is in the initial acute phase of a CDC Clinical Category C infection at Baseline. Subjects may be enrolled provided they are receiving treatment for such infections and are clinically improving at the Baseline visit. 2. Subject is enrolled in one or more investigational drug protocols, which may impact HIV RNA suppression. 3. Subject is, in the opinion of the Investigator, unable to complete the study dosing period and protocol evaluations and assessments. 4. Patients with severe hepatic impairment (CTP score >9) 5. Patients with HBV co-infection 6. Subject has evidence of genotypic (as defined by the current ANRS AC-11 algorithm) resistance to Telzir at screening or prior documented evidence of genotypic and/or phenotypic (above threshold for reduced susceptibility) resistance to amprenavir/ritonavir,. 7. Patients with alcohol and drug use problems that in the view of investigator will compromise participation in the study will be excluded. 8. Exclude patients receiving HCV treatment in first 48 weeks of study 9. Subject is either pregnant or breastfeeding. 10. Subject suffers from any serious medical condition (such as pancreatitis, diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction), which in the opinion of the Investigator, would compromise the safety of the subject. 11. Subject has a pre-existing mental, physical, or substance abuse disorder that, in the opinion of the Investigator, may interfere with the subject’s ability to comply with the dosing schedule and protocol evaluations and assessments. 12. Subject has a history of inflammatory bowel disease or intestinal malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which, in the opinion of the Investigator, may interfere with drug absorption or render the subject unable to take oral medication. 13. Subject has any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the 45-day screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation. 14. Subject has an estimated creatinine clearance 5 times the upper limit of normal (ULN). 16. Subject is receiving, or has received within 90 days prior to screen, any drug that has been classified as ‘contraindicated’ from use with fpv/r. 17. Subject has received treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period. 18. Subject has received treatment with an HIV-1 immunotherapeutic vaccine or any agents with documented activity against HIV-1 in vitro within 28 days prior to screening, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether Telzir can be safely used in patients with HIV/HCV co-infection, and those with hepatic impairment, and to evaluate whether these patients benefit from dose adjustments? To evaluate the hepatic safety/tolerability of FPV/rtv (Telzir)- containing HAART, at 48 weeks as measured by the incidence of grade 3-4 LFT elevations ;Secondary Objective: To describe the effect of FPV/rtv on clinical progression of hepatic disease. To evaluate the role of non-invasive markers (APRI, Forns index, SHASTA) and Fibroscan in the evaluation and monitoring of patients with HIV/HCV co-infection. To investigate the role of therapeutic drug monitoring (TDM) in the evaluation and management of these patients. To assess the role of TDM in monitoring/treatment adjustment in patients with liver fibrosis/cirrhosis receiving FPV/rtv. To describe the overall safety of FPV/rtv in patients with mild or moderate hepatic impairment. ;Primary end point(s): Incidence of grade 3-4 increases in ALT or AST over 48 weeks. | — |
Countries
Ireland, Spain
Outcome results
None listed