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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000243-50-IT

Enrollment

210

Registered

2021-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection MedDRA version: 20.0 Level: LLT Classification code 10020441 Term: Human immunodeficiency virus infection, unspecified System Organ Class: 100000004862

Interventions

Trade Name: Lamivudina Product Name: Lamivudina Product Code: [-] Pharmaceutical Form: Tablet INN or Proposed INN: LAMIVUDINA CAS Number: 134678-17-4 Current Sponsor code: - Concentration unit: mg mil

Eligibility

Sex/Gender

All

Inclusion criteria

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=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. To characterize resistance mutations at virological failure. To analyze CD4, CD4/CD8 and HIV-1 DNA variation at 48 weeks. 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	—

Measure

Time frame

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. To characterize resistance mutations at virological failure. To analyze CD4, CD4/CD8 and HIV-1 DNA variation at 48 weeks. 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

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Countries

Italy

Contacts

Public ContactImmunodeficienze Virali

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

immunodeficienzevirali@inmi.it0655170477

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026