An open label safety study of fosamprenavir/ritonavir (FPV/rtv (Telzir)) administered to HIV/HCV co-infected patients over 96 weeks - Telzir/Hep C Study
- Conditions
- Antiretroviral - Naive HIV-1 Infected Adults and Antiretroviral Experienced HIV-1 Infected AdultsMedDRA version: 9.1Level: LLTClassification code 10008922Term: Chronic infection with HIV
- Registration Number
- EUCTR2008-001749-25-IE
- Lead Sponsor
- Mater Misericordiae University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
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
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 < 50 mL/min via the Cockcroft-Gault method [Cockcroft, 1976]. This test may be repeated once within the 45-day screening window.
NOTE: Creatinine clearance should be estimated using the following formula:
For serum creatinine concentration in mg/dL:
( ) ( ) (0.85 for women only)
serum creatinine x 72
140 - age weight in kg ×
For serum creatinine concentration in µmol/L:
(140 - age) (weight in kg ) (serum .8 × 0.85 for women only) creatinine
15. Alanine aminotransferase (ALT) >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method