arge, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study) - SMART

Phase 1

• Conditions: HIV infection

• Registration Number: EUCTR2004-000441-38-AT
• Lead Sponsor: ational Institute of Allergy and Infectious Diseases, National Institutes of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-22
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

1. Signed informed consent
2. Evidence of HIV infection (positive ELISA and Western Blot and/or documented history of measurable HIV RNA)
3. Age > 13 years (in effect 18 years at most sites)
4. Current CD4+ cell count > 350 cells/mm3 (within 45 days prior to randomization)
5. Willing to initiate, modify, or stop antiretroviral therapy, in accordance with the randomized assignment
6. If participating in sexual activity that could lead to pregnancy, willingness to use acceptable contraception methods
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

1. Current participation in the CPCRA FIRST, MDR-HIV or another study which is not consistent with one of the treatment groups in the SMART study (e.g., ESPRIT or SILCAAT).

2. Current pregnancy or breastfeeding

Study & Design

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