Strategic Timing of AntiRetroviral Treatment (START)
START is an international randomized trial comparing early ART versus deferred ART. Participants will be randomized in a 1:1 allocation ratio to the early or deferred ART group. The primary composite endpoint is the development of a serious AIDS event, a serious non-AIDS event ([Double Quote]non-AIDS[Double Quote]), or death from any cause.
Participants that enroll will be randomized to one of 2 groups:
Early treatment group - participants will start taking HIV medicines right away after enrollment.
Deferred treatment group - participants will wait to start HIV medicines until their CD4+ cell count drops to below 350 cells/mm3, or until they develop other symptoms of HIV infection. (This is the current standard of care.)
The primary endpoint includes the following three major components:
* AIDS* or death from AIDS
Opportunistic events consistent with the 1993 CDC expanded surveillance definition plus additional events associated with immunosuppression in the patient population targeted for enrollment. Esophageal candidiasis and chronic Herpes simplex infection will be counted as primary endpoints only if they result in death.
- CVD: myocardial infarction, stroke, coronary revascularization
- ESRD: initiation of dialysis, renal transplantation
- Decompensated liver disease
- Non-AIDS-defining cancers, excluding basal and squamous cell skin cancers. Basal and squamous cell skin cancer will be counted as a primary endpoint only if they result in death.
* Death not attributable to AIDS, including death of unknown cause
The primary outcome of START and each of the major components of the primary outcome will be evaluated as the time to the first occurrence of an event above.
• Signed informed consent
• HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed 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 (Note: Once the target enrollment of 4,000 has been reached, the final 600 participants enrolled will be ages 35 or older.)
• 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