Strategic Timing of Antiretroviral Treatment - START

Phase 1

• Conditions: HIV patient; MedDRA version: 9.1Level: LLTClassification code 10064446; MedDRA version: 9.1Level: LLTClassification code 10020161

• Registration Number: EUCTR2008-006439-12-IT
• Lead Sponsor: Regents of the University of Minnesota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-04
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

HIV infection, age>18 year karnosfky index > 80, Perceived life expectancy of at least 6 months; CD4> 500 cell
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any previous use of ART or IL-2, Diagnosis of any clinical AIDS event; Cardiovascular event; History of decompensated liver disease; Current pregnancy or breastfeeding

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS* (AIDS with an asterisk include most traditional opportunistic conditions but exclude nonfatal esophageal candidiasis and chronic Herpes simplex) non-AIDS, or death from any cause;Secondary Objective: To compare early ART to deferred ART for the following secondary outcomes:All-cause mortality, Non- AIDS, CVD, ESRD, Decompensated liver disease, Non-AIDS malignancy, AIDS, Bacterial pneumonia, Adverse events, Hospitalisation, QoL.;Primary end point(s): presence of AIDS or death from AIDS Opportunistic events