Switch from a current boosted rtv PI to ATV/rtv based HAART regimen. Effect on metabolic and hepatic toxicity in HIV/HCV coinfected patients (COAT Study). - COAT

• Conditions: co-infection HIV-1/HCV; MedDRA version: 9.1Level: LLTClassification code 10020443Term: Human immunodeficiency virus syndrome; MedDRA version: 9.1Level: PTClassification code 10019738Term: Hepatitis B positive

• Registration Number: EUCTR2008-004627-28-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-11
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 50 copies/ml in two consecutively examination in the previous 3 months. The last will be not older than 30 days 7. Any CD4 cell count are admitted 8. HCV genotype available 9. Engagement do not procreate 10. Patients can comply with the protocol requirements 11. Atazanavir naive
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) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified