A pilot, open label, randomised clinical trial assessing the 12 week immunological response in HIV-1 failing subjects receiving monotherapy with emtricitabine 200 mg once a day or emtricitabine 200 mg once a week or lamivudine 300 mg once a day - The Break Study

Conditions: HIV-Infection
MedDRA version: 6.1Level: PTClassification code 10000565

Registration Number: EUCTR2006-001681-16-IT

Lead Sponsor: FONDAZIONE NADIR ONLUS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Subject is 18 years old Subject has given written informed consent Subject is in virological failure Subject has a screening CD4 count 8805; 500 cell/mm3 Subject is on a HAART regimen including lamivudine unchanged from at least 12 weeks Screening genotype evidencing Met 184V mutation genotype performed within 90 days before screening
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

Subject has positive Hepatitis B surface antigen. Subject has an active opportunistic infection. Subject has been treated with interleukin 2, other immunomodulants or chemotherapeutics in the previous six months Subject is pregnant or wishes to become so.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The general aim of the BREAK study is to evaluate whether there is a difference in the 12 week immunological response in HIV-1 failing subjects receiving monotherapy with emtricitabine EMTRIVA 200 mg once a day or emtricitabine EMTRIVA 200 mg once a week or lamivudine EPIVIR 300 mg once a day;Secondary Objective: -proportion of patients not in immunological failure -changes in absolute number and percentages of CD4 and CD8 cell count and HIV-RNA level, -proportion of patients resuming HAART, -proportion of patients with occurrence of B or C CDC events, -proportion of patients maintaining the Met 184V mutation at week 24 or at study discontinuation;Primary end point(s): Primary end-point will be the proportion of patients with immunological response over a 12-week period in the three groups.

Secondary Outcome Measures