HIV infection
Conditions
Interventions
Pharmaceutical Form:
Sponsors
National Institute of Allergy and Infectious Diseases, National Institutes of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Evidence of HIV infection (positive ELISA and Western Blot and/or documented history of measurable HIV RNA) 3. Age > 13 years (in effect 18 years at most sites) 4. Current CD4+ cell count > 350 cells/mm3 (within 45 days prior to randomization) 5. Willing to initiate, modify, or stop antiretroviral therapy, in accordance with the randomized assignment 6. If participating in sexual activity that could lead to pregnancy, willingness to use acceptable contraception methods Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current participation in the CPCRA FIRST, MDR-HIV or another study which is not consistent with one of the treatment groups in the SMART study (e.g., ESPRIT or SILCAAT). 2. Current pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the drug conservation (DC group) strategy with the viral suppression (VS group) strategy in delaying clinical disease progression or death. ;Secondary Objective: 1. To compare the DC group with the VS group for the following: - Survival, Incidence of major cardiovascular and metabolic complications, Incidence of serious disease progression events, Combined endpoint of clinical disease progression, major cardiovascular and metabolic complications, or death, Grade 4 adverse events, Self-reported changes in body appearance, Adherence to antiretroviral treatment, averaged over follow-up, Disease progression, death, and other outcomes above within subgroups. 2.In subsamples of patients, to compare the DC and VS groups for other major disease outcome, Quality of life, HIV transmission risk behaviors, Health care utilization and costs 3. To conduct nested case-control studies in subsamples of patients on predictors of survival and clinical disease progression. 4. To study predictors of survival, disease progression, and major cardiovascular and metabolic complications. 5. Inaddition other protocol defined analyses will be conducted.;Primary end point(s): Time to disease progression or death. (The events constituting “disease progression” are opportunistic events that are consistent with the 1993 CDC expanded surveillance definition for clinical AIDS. These events are defined in the CPCRA Clinical Events Handbook and in a paper describing event documentation and review procedures. Other Major Endpoints include: -Survival -Time to major cardiovascular events: myocardial infarction, coronary artery disease requiring treatment or an invasive procedure, or stroke. (These events are defined in the CPCRA Supplemental Events Handbook.) - Time to “serious” disease progression event, including death. A serious event for this protocol is defined as one of the following: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AID | — |
Countries
Austria, Ireland, Italy
Outcome results
None listed