None listed
Conditions
Interventions
Group 1 Type of group
Initiate ART immediately following randomization
Group name:Group 2 Type of group
Defer ART until the CD4+ count declines to
Sponsors
Universidad de Minnesota - EEUU,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:AIDS event or death by AIDS: Opportunistic events that meet the definition of expanded surveillance of the 1993 CDC plus additional events associated with immunosuppression in the patient population to be included in the study. Esophageal candidiasis and chronic Herpes simplex infection will be counted as primary endpoints only if they lead to death. Non-AIDS event: Cardiovascular disease (CVD): myocardial infarction, accident, cerebrovascular, coronary revascularization, End stage renal disease (ESRD): onset of dialysis, transplanterenal, Decompensated liver disease. Death not attributable to AIDS, even death due to unknown cause Measure:Time to an AIDS event, non-AIDS or death from any cause (first event) Timepoints:4.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:AIDS event or death by AIDS: Opportunistic events that meet the definition of expanded surveillance of the 1993 CDC plus additional events associated with immunosuppression in the patient population to be included in the study. Esophageal candidiasis and chronic Herpes simplex infection will be counted as primary endpoints only if they lead to death. Measure:Time to an AIDS event or death from AIDS Timepoints:4.5 years ; Outcome name:Non-AIDS event: Cardiovascular disease (CVD): myocardial infarction, accident, cerebrovascular, coronary revascularization, End stage renal disease (ESRD): onset of dialysis, transplanterenal, Decompensated liver disease. Death not attributable to AIDS, even death due to unknown cause Measure:Time to a non-AIDS event or death not attributable to AIDS Timepoints:4.5 years | — |
Countries
Argentina, Australia, Belgium, Brazil, Chile, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Luxembourg, Malasya, Mali, Mexico, Morocco, Nigeria, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kindgdom, United States
Contacts
Public ContactRomina Chinchay
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION
Outcome results
None listed