Study before-after”: Adherence Evaluation to antiretroviral therapy administered in two different ways

Conditions: HIV infection
MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-004935-30-IT

Lead Sponsor: .L.S.S. 9 DI TREVISO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- age: at least 18 years old or older - patient treated with Truvada or Kivexa or Combivir and 3th drugs or Atripla for at least 6 months - Viral load < 20 cp/ml for at least 6 months - Patient able and willing to provide signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients who are at risk of non adherence (alcoholic abuse, intravenous drug users, dementia, language difficulties, homeless).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To compare the adherence in the two groups receiving the same HAART with different kind of administration (co-formulated versus multiple pills).;Primary end point(s): Evaluation of the adherence difference between baseline and 4-6 months afterwards in the two groups, one switched from co-formulated therapy to more pills, and one continuing co-formulated therapy.;Timepoint(s) of evaluation of this end point: 4-6 months;Main Objective: To compare the adherence in the group switching from co-formulated drugs to multiple pills.

Secondary Outcome Measures