A pilot phase II study of a nucleoside sparing regimen of Dolutegravir + Atazanavir/r in HIV-1 infected patients with detectable viremia (Dolatav Study)

Phase 1

• Conditions: HIV-1 infected patients; MedDRA version: 20.1Level: LLTClassification code 10008922Term: Chronic infection with HIVSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001206-33-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-27
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Subjects with age >18 years
•Willing and able to provide informed consent
•Failing a stable (at least 3 months) antiretroviral therapy (HIV-RNA > 200 copies/ml)
•Any CD4 cell count
•HBsAg non reactive
•Virus susceptible to atazanavir, defined as a genotypic mutation score < 15 according to the HIV drug resistance database (Stanford University)
• No previous exposure to integrase inhibitors
•Absolute neutrophil count (ANC) ¿500/mm3
•Haemoglobin¿8.0 g/dL
•Platelet count¿60,000/mm3
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ¿ 5 ¿ ULN
•Total bilirubin ¿ 2.5 x ULN
•e-GFR> 60 ml/min using CKD-EPI equation

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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (see 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 >35% direct bilirubin)
•Subjects positive for Hepatitis B at screening (HBsAg+)
•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; appendix 7) 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.

Study & Design

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