Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Atazanavir Sulfate; Maraviroc; Ritonavir

Criteria

Inclusion Criteria:

• age>18 years;

• confirmed HIV-antibodies positivity;

• signed informed consent;

• HIV-RNA <20 cp/ml for the last 24 months;

• no virological failures to PI regimens;

• no major PI resistance associated mutations;

• genotypic tropism for CCR5 co-receptor.

Exclusion Criteria:

• active opportunistic infections or neoplasms;

• need for drugs with known drug-drug interactions with included drugs;

• liver cirrhosis;

• any evidence of tropism for CXCR4 or dual infection;

• pregnancy;

• self-reported adherence<90%;

• HBsAg positivity;

• detectable HCV RNA.