co-infection HIV-1/HCV MedDRA version: 9.1 Level: LLT Classification code 10020443 Term: Human immunodeficiency virus syndrome MedDRA version: 9.1 Level: PT Classification code 10019738 Term: Hepatitis B positive
Conditions
Interventions
Trade Name: REYATAZ*FL 60CPS 150MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Atazanavir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Na
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with documented HIV-1/HCV (HCV-RNA detectable at quantitative assay) co-infection 2. Male or female ages > 18 years old 3. Patients who have voluntarily signed and dated the CI 4. Patients currently receiving a PI based HAART for at least 24 weeks (HAART is defined as the combination of 2 NRTIs with one boosted PI) 5. Patients taking the same ARV combination for at least 8 weeks before enrolment 6. Plasma HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of virological failure defined as two consecutive plasma HIV-RNA > 400 copies/ml while on previous or current antiretroviral therapy 2. History of PI mutations uncompatible with ATV/rtv simplification (<4 primary PI mutations) as defined by the IAS-USA guidelines 2006 3. Use of interferon or ribavirin in the past 4. Need to use pegIFN/RBV in the next two years 5. Diagnosis of cirrhosis 6. Patients co-infected with HBV (HBsAg+) 7. Patients with a grade 3/4 laboratory abnormality defined by DAIDS grading table with the following exceptions: &#61656; Patients with pre-existing triglycerides or cholesterol elevation grade 3 or 4 without history of CVD &#61656; Patients with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 &#61656; Presence of any currently active AIDS defining illness (Category C conditions according to the CDC classification System for HIV infection 1993) with the following exceptions: &#61607; Stable cutaneous Kaposi?s Sarcoma (i.e no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study &#61607; Wasting syndrome due to HIV infection Note: An AIDS defining illness that is not clinically stabilized for at least 30 days will be considered as currently active. 8. Pregnant and breastfeeding women 9. Active drug abuse including alcohol or recreational drugs which, in the opinion of the investigator is expected to interfere with the patient?s ability to adhere to the study procedures and treatment regimen. Patients on a methadone program will be accepted if deemed appropriate by the investigator 10. Any active clinically significant diseases or life threatening diseases or findings during screening of medical history or physical examination that in the investigator?s opinion, would compromise the patient?s safety and outcome of the study 11. Previously demonstrated clinically allergy or hypersensitivity to any excipients of the investigational medication (ATV) 12. Hypersensitivity to ritonavir or to any of the other ingredients found in ritonavir tablet 13. Use of disallowed concomitant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the metabolic toxicity in patients who switch to boosted ATV compared to others boosted PIs in HIV/HCV co-infected patients.;Secondary Objective: To compare change in hepatic and metabolic profile from baseline to week 24, 48 and 96 of a ATV/rtv versus a other boosted PI containing HAART To assess and compare the resolution of toxicities present at the screening visit over 48 and 96 week in both groups To compare steatosis and fibrosis progression from baseline to week 96 of a ATV/rtv versus a other boosted PI containing HAART To evaluate PK (Ctrough) in a subgroups of HIV/HCV patients in both arms stratified by grade of fibrosis To assess the patients reported antiretroviral medication adherence visit in both treatment groups.;Primary end point(s): Proportion of patients with fasting different grade of insulin sensitivity at week 96: Grade 1) Insulin resistance defined as a) HOMA-IR score 3-5 b) HOMA-IR > 5 Grade 2) Impaired fasting glucose [Fasting plasma glucose > 110 mg/dl (6.1 mmol/l) but 126 mg/dl) or 2 h glucose concentration of OGTT > 200 mg/dl or random plasma glucose level > 200 mg/dl] | — |
Countries
Italy
Outcome results
None listed