Combination of Atazanavir and Raltegravir as Dual Strategy - CARDS STUDY
- Conditions
- Documented HIV infection
- Registration Number
- EUCTR2009-014656-30-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
i. Age > 18 years
ii. Documented HIV infection
iii. Written informed consent
iv. Antiretroviral experienced patients
v. Effective ongoing treatment (HIV-RNA < 50 copies/ml for longer than 6 months and at least for 3 consecutive evaluations).
vi. Extensive resistance to the current NRTI-backbone, according to genotype, or NRTI-related toxicity for which patient might benefit from switching his/her regimen.
vii. No documented genotypic resistance to protease inhibitors
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
i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
ii. Any ongoing grade 4 laboratory abnormality, but for lipid alterations
iii. Patients requiring chronic proton pump inhibitors.
iv. Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit.
v. History or suspected poor adherence to HAART.
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