Strategic long term, immunologically driven treatment interruptions in previously naive patients starting HAART: a controlled, randomized, multicenter study - (Therapeutic Structured Interruptions Study)

• Conditions: HIV INFECTION; MedDRA version: 9.1Level: HLTClassification code 10052740Term: Acquired immunodeficiency syndromes

• Registration Number: EUCTR2006-002805-30-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a. Inclusion i. Age > 18 years ii. Informed consent signed iii. Being naive for ARV therapy iv. CD4 cell count nadir and current CD4 count > 200 cells/L
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

i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviors ii. Any ongoing grade 4 laboratory abnormality iii. Previous diagnosis of AIDS iv. Active HBV co-infection v. Previous HIV-related AEs such as, but not limited to thrombocytopenia (platelets < 10.000/L)

Study & Design

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