Randomised trial comparing the introduction of an immediate or deferred new HAART regimen in failing HIV infected patients: the role of lamivudine monotherapy - ND

Phase 1

• Conditions: HIV infected patients; MedDRA version: 9.1Level: LLTClassification code 10000807Term: Acute HIV infection

• Registration Number: EUCTR2009-010189-48-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-09
• Study Completion: 2012-05-28
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

adukt patients affected by HIV in unchanged antiretroviral therapy from at least 12 weeks, in virologic failure with HI84V mutation
Are the trial subjects under 18? yes
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

positivity for Hb3AQ; active opportunistic infections; pregnancy;

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to verify if 6 months of monotherapy with Lamivudine followed by 6 months of HAART therapy has better virologic efficacy at 48 week in confront with 48 weeks of HAART therapy.;Secondary Objective: -to evaluate immunological and metabolical changes; -to evaluate the types and numbers of mutations associated to drug resistance; -evaluation of CDC o B events and deaths;;Primary end point(s): evaluation at week 48 of treatment of the parcent of patients in virologic suppression in the 2 different group of therapy