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NATIONAL, MULTICENTER, RANDOMIZED,OPEN STUDY TO EVALUATE EFFICACY AND SAFETY OF LAMIVUDINE (300 MG QD) MONOTHERAPY AS AN ALTERNATIVE TO THERAPEUTIC INTERRUPTION IN PAZIENTS AFFECTED BY HIV-1, IN VIRAL FAILURE, WITH M184V MUTATION.

NATIONAL, MULTICENTER, RANDOMIZED,OPEN STUDY TO EVALUATE EFFICACY AND SAFETY OF LAMIVUDINE (300 MG QD) MONOTHERAPY AS AN ALTERNATIVE TO THERAPEUTIC INTERRUPTION IN PAZIENTS AFFECTED BY HIV-1, IN VIRAL FAILURE, WITH M184V MUTATION.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001590-26-IT
Enrollment
Unknown
Registered
2004-09-17
Start date
2004-09-15
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

HIV MONOTHERAPY TREATMENT , AS THERAPEUTIC MAINTENANCE, DURING INTERRUPTION OF ANTIVIRAL THERAPY MedDRA version: 6.1 Level: SOC Classification code 10021428

Interventions

Trade Name: Epivir Fl 30cpr riv 300mg Product Name: lamivudina Pharmaceutical Form: Coated tablet INN or Proposed INN: Lamivudine CAS Number: 134678-17-4 Concentration unit: mg milligram(s) Concentrat

Sponsors

OSPEDALE S. RAFFAELE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

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