Study of pharmacological characteristics of antiretroviral drugs atazanavir/ritonavir and maraviroc in stable HIV-positive patients

Phase 1

• Conditions: HIV infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004692-22-IT
• Lead Sponsor: niversity of Torino

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-15
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-age>18 years;
-confirmed HIV-antibodies positivity;
-signed informed consent;
-HIV-RNA<20 cp/ml for last 24 months, at least;
-no virological failures to PI regimens;
-no major PI resistance associated mutations;
-genotypic tropism for CCR5 co-receptor.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-active opportunistic infections or neoplasms;
-need for drugs with known drug to drug interactions with included drugs (rifampicin, proton pump inhibitors);
-liver cirrhosis;
-any evidence of tropism for CXCR4 or dual infection.

Study & Design

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