nderstanding the Impact of HIV-DNA resistance mutations detected by NGS in Simplificationstrategies to 2-Drug Regimens for patients virologically suppressed with previous failures and/orprevious resistance mutations: a prospective multi-centre intervention study (INS-2DR)

Phase 1

• Conditions: HIV infection; MedDRA version: 20.0Level: LLTClassification code 10020441Term: Human immunodeficiency virus infection, unspecifiedSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000243-50-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

i) HIV-1 infection;
ii) age >= 18 years;
iii) history of previous virological failures and/or previous resistance mutations to NRTI or NNRTI;
iv) HIV-RNA< 50 copies/ml for <=3 years, with last determination in the previous 2 months;
v) on any ART apart from DTG + NRTI or DTG+NNRTI;
vi) written informed consent.
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

i) multiple class drug resistance or known dolutegravir resistance;
ii) HBsAg positivity;
iii) women of childbearing potential not adopting an effective birth control system throughout the study period
iv) pregnancy
v) relevant psychiatric disease
vi) creatinine clearance of <50 mL/min/1.73m2

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the impact of HIV-1 resistance mutations detected in proviral DNA by NGS on virological efficacy of 2-drug regimens in virologically suppressed HIV+ patients with history of previous failures, and/or previous resistance mutations.;Secondary Objective: To investigate predictors of loss of viral efficacy (viral rebounds or viral blips) in the study population.<br>To characterize resistance mutations at virological failure.<br>To analyze CD4, CD4/CD8 and HIV-1 DNA variation at 48 weeks.<br>Cost-efficacy analysis.;Primary end point(s): Proportion of patients who maintained HIV-RNA<50 copies/mL at 48 weeks.;Timepoint(s) of evaluation of this end point: 48 weeks