Strategic Timing of AntiRetroviral Treatment 

Study Objective

This is a multicenter, international, randomized trial for HIV-infected adults comparing initiation of ART at a CD4+ cell count > 500 cells/mm3 (early ART) versus initiation of ART at a CD4+ cell count of < 350 cells/mm3 (deferred ART) for a composite outcome of AIDS*, non-AIDS, and death from any cause. The primary objective is to determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS*, non-AIDS, or death from any cause.

Participation conditions

Inclusion criteria

• Signed informed consent
• HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed1 ELISA test; and confirmed by another test using a different method, including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
• Age > 18 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 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 at randomization
• 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
• Diagnosis of decompensated liver disease before randomization
• 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)

Centre Hospitalier de Luxembourg