Strategic Timing of AntiRetroviral Treatment(START) - START

Not Applicable

Completed

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-032-09
• Lead Sponsor: niversidad de Minnesota - EEUU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Study Completion: 2022-03-30
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Signature of informed consent
• Documented HIV infection by HIV-RNA plasma viral load, rapid HIV test or any approved ELISA test ´´; and confirmed by a different method such as rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to entering the study.
• Age> 18 years
• Karnofsky score> 80 (indicator that the participant can carry out normal activities)
• Perceived life expectancy of at least 6 months
• For women of childbearing age, willingness to use contraceptives as described in the product information of prescription ART medications.
• 2 CD4 + cell counts> 500 consecutive cells / mm3, separated by at least two weeks within 60 days prior to randomization.

Exclusion Criteria

• History of the use of antiretroviral treatment (ART) or lL-2.
• Diagnosis of any defining clinical event of AIDS prior to randomization (esophageal candidiasis and chronic Herpes simplex infection are included)
• Evidence of progression of HIV disease such as oral thrush, weight loss or fever of no clear cause.
• Cardiovascular event (myocardial infarction, angioplasty, coronary bypass graft, stroke) within 6 months prior to randomization
• Non-defining AIDS cancer, basal cell and squamous cell carcinomas are excluded, within 6 months prior to randomization.
• Dialysis within 6 months prior to randomization *
• History of decompensated liver disease
• Current mandatory confinement or detention (Involuntary imprisonment) for the treatment of a psychiatric or physical illness
• Pregnancy or current lactation (a negative serum or urine pregnancy test is required, within 14 days prior to randomization for women with fertile potential)

Study & Design

• Study Type: Interventional
• Study Design: Not specified