None listed
Conditions
Interventions
Drug Preservation Group (PM) Type of group
[Stop or delay ARV therapy until the CD4 + count drops below 250 cel / mm3
then try to increase CD4 + counts> 350 cel / mm3
Viral Suppression Group (SV)
Type of group
[Use ARV treatment to keep the viral load as low as possible without taking into account the CD4 + count, and change the ARV treatment when there is no viral load suppression]
Sponsors
DIVISION DE SIDA (DADIS) E.U.A,
Eligibility
Inclusion criteria
Inclusion criteria: • Signed informed consent • Evidence of HIV infection (ELISA positive, and Western Blot positive and / or history of detectable HIV RNA) • Age> 13 years • CD4 + cell count> 350 cell / mm ^ 3 (within 45 prior to random assignment) • Be willing to initiate, modify, or discontinue antiretroviral treatment, in accordance with random assignment • In the case of engaging in sexual activity that may result in pregnancy, you must be willing to use appropriate contraceptive methods.
Exclusion criteria
Exclusion criteria: • Be currently participating in the FIRST or MDR-HIV studies of CPCRA or any other study that is not consistent with the SMART study treatment groups (for example, ESPRIT or SILCAAT). • Current pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The events that constitute progression of infection are opportunistic events that match the 1993 CDC definition for clinical AIDS. Measure:The moment of progression of the infection or death Timepoints:During the study and follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serious events are considered in this study: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi sarcoma (visceral), dementia-AIDS complex (CDS), toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacierium avium Complex (MAC) infection, cachexia and cytomegalovirus (CMV) infection Measure:Time to acute events of disease progression and death Timepoints:During the study and follow-up ; Outcome name:Myocardial infarction (based on a review of the medical history or serial changes in the ECG that indicate significant changes in Q waves), coronary insufficiency that requires invasive treatment or procedure, myocarditis or pericarditis, cerebrovascular accident, diabetes mellitus, pancreatitis , lactic acidosis or osteonecrosis Measure:Time until the onset of cardiovascular or metabolic events Timepoints:During the study and follow-up ; Outcome name:myocardial infarction, coronary insufficiency requiring invasive treatment or procedure, or cerebrovascular accident (these events are described in the CPCRA Event Manual Supplement). Measure:Time until the onset of acute cardiovascular events Timepoints:During the study and follow-up | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Mauritania, New Zealand, Norway, Poland, Spain, Switzerland, Thailand, United Kindgdom, United States
Outcome results
None listed