A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia

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

Summary

Research ipotesis is to assess the efficacy and safety of a nucleos(t)ide sparing regimen of atazanavir/ritonavir 300 mg /100 mg QD + Dolutegravir 50 mg QD for the management of virological failure in HIV-1 infected patients.

The Primary Objective is to explore the 24-week efficacy of a nucleos(t)ide sparing regimen of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of virologic failure in HIV-1 infected, integrase inhibitor-naïve subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Castagna Antonella
• Collaborators: Bristol-Myers Squibb; ViiV Healthcare
• Treatments: Atazanavir Sulfate; Dolutegravir; Ritonavir

Criteria

Inclusion Criteria:

• Subjects with age more than 18 years

• Willing and able to provide informed consent

• Failing a stable (at least 3 months) antiretroviral therapy (HIV-RNA more than 200 copies/ml)

• Any CD4 cell count

• Virus susceptible to atazanavir, defined as a genotypic mutation score inferior to 15 according to the HIV drug resistance database (Stanford University)

• No previous documented virologic failure during an atazanavir-containing regimen

• No previous exposure to integrase inhibitors

• Absolute neutrophil count (ANC) more than 500/mm3

• Haemoglobin more than 8.0 g/dL

• Platelet count more than 60,000/mm3

• e-GFR> 60 ml/min using CKD-EPI equation

Exclusion Criteria:

• Active AIDS-defining condition at Screening

• Serious illness requiring systemic treatment and/or hospitalization

• Current use of immunomodulant or immunosuppressive drugs

• Requirement for any concomitant medications that are prohibited with any study drugs (protocol section 3.6)

• History or presence of hypersensitivity to any of the active substances or to the excipients

• Alanine aminotransferase (ALT) more than 5 times the upper limit of normal (ULN), OR ALT more than 3xULN and bilirubin more than 1.5xULN (with more than 35 percent direct bilirubin)

• Subjects positive for Hepatitis B at screening (HBsAg positive)

• Subjects with anticipated need for Hepatitis C virus (HCV) therapy during the study

• Presence of moderate or severe hepatic impairment (defined as a Class B or C at Child Pugh Classification) or presence of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• Pregnancy or pregnancy wish; breastfeeding

Moreover, all clinical conditions reported as an absolute contraindication in the summary of product characteristics of the study drugs, will be considered as exclusion criteria.