A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)

The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.

The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies. Condition:- HIV Infections Study Type: ObservationalStudy Design: Natural History, Longitudinal, Defined Population, Prospective Study Official Title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)Further Study Details: Implementation of antiretroviral treatment (ART) guidelines, which emphasize maximal and durable suppression of viral load for the majority of individuals infected with HIV, has resulted in a substantial decline in morbidity and mortality. However, many asymptomatic patients are not at immediate risk of serious opportunistic diseases, the effectiveness of ART wanes over time due to HIV drug resistance, and there are short- and long-term toxicities of treatment. This motivates a comparison of two strategies: one which conserves treatments by deferring their use while the risk of opportunistic disease is low and one which aims for sustained virologic suppression, irrespective of disease risk. In this large, long-term trial, patients will be randomly assigned to either the drug conservation (DC) or viral suppression (VS) group. Patients will be enrolled over a 3-year period and followed for an average of 7.5 years. The DC group will stop or defer ART until CD4 cell count declines to below 250 cells/mm3; they will then receive treatment to increase CD4 count to greater than 350 cells/mm3 followed by episodic ART based on CD4 cell count. The VS group will use ART to maintain viral load as low as possible, irrespective of CD4 cell count. Patients will be seen Months 1, 2, 4, 6, 8, 10, and 12, then every 4 months for data collection visits. All available ARTs, including immunomodulators, and resistance testing may be used by patients in both treatment groups. Selected subsamples of patients enrolled in the study will be followed with more intensive data collection for secondary outcomes relating to cost and health care utilization, quality of life, HIV transmission risk behaviors, and metabolic complications of treatment. Eligibility Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both Criteria Inclusion CriteriaHIV infection CD4 cell count greater than 350 cells/mm3 within 45 days of study entry Willing to start, change, or stop antiretroviral therapy Acceptable methods of contraception Good health at the time of study entry Available for the study for at least 6 months Able, in the clinician’s opinion, to comply with the protocol Exclusion CriteriaCurrently participating in the CPCRA FIRST, MDR-HIV, or NvR study or another study which is not consistent with one of the treatment groups in this study Pregnant or breast-feeding Expected Total Enrollment: 6000AustraliaAlfred Hosp, Prahan, Australia; Recruiting Sally Algar 03 9276 6908 clinresearch@alfred.org.au National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia; Recruiting Jennifer Hoy 61 3 9276 6900 jennifer.hoy@med.monash.edu.au Royal Perth Hosp, Perth, Australia; Recruiting Jenny Leung 61 8 9224 3429 jennifer.leung@health.wa.gov.au Royal Prince Alfred Hospital, Prahan, Australia; Recruiting Marry Moussa 61-2 9515 6111 marry.moussa@email.cs.nsw.gov.au Burwood Street General Pratice, Burwood NSW, 2134, Australia; Recruiting Jeff Hudson (+61) 2 9745 2755 burwood8@bigpond.net.au Australia, South AustraliaRoyal Adelaide Hospital, Adelaide, South Australia, Australia; Recruiting Wendy Ferguson 61 8 8222 5635 Australia, VictoriaPrahran Market Clinic, South Yarra, Victoria, Australia; Recruiting Helen Wood 61-3 9826 4500 helenwood@netspace.net.au The Centre Clinic, South Yarra, Victoria, Australia; Recruiting Helen Wood 61-3 9826 4500 helenwood@netspace.au