Strategic Timing of AntiRetroviral Treatment

Phase 4

• Conditions: HIV-Infection

• Registration Number: DRKS00000374
• Lead Sponsor: niversity of Minnesota Clinical and Translational Science Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-22
• Study Completion: 2019-09-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4625

Inclusion Criteria

· Signed informed consent· HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed[1] ELISA test; and confirmed by another test using a different method such as a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.· Age >= 35 years· Karnofsky performance score >= 80 (an indication that the participant can perform normal activities)· Perceived life expectancy of at least 6 months· For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed· Two consecutive CD4+ cell counts > 500 cells/mm3 at least 2 weeks apart within 60 days before randomization

Exclusion Criteria

· Any previous use of ART or IL-2· Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection)· Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever · Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization· Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization· Dialysis within 6 months before randomization· History of decompensated liver disease· Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness· Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality