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

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00027352

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

6000

Last updated by the study team

2009-11-25

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV 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

You may not qualify if…

• Currently participating in the MDR-HIV, NvR study, or another study which is not consistent with one of the treatment groups in this study. CPCRA FIRST participants may be screened for SMART after August 8, 2005 and can be randomized into SMART on or after September 19, 2005.
• Pregnant or breast-feeding

Where it is running

• AIDS Healthcare Foundation — Los Angeles, California, United States
• Los Angeles Gay and Lesbian Community Service Ctr — Los Angeles, California, United States
• Community Consortium / UCSF — San Francisco, California, United States
• Dr. Shawn Hassler — San Francisco, California, United States
• East Bay AIDS Ctr — San Francisco, California, United States
• Lawrence Goldyn, MD — San Francisco, California, United States
• Drs. Lichtenstein & Greenberg — Denver, Colorado, United States
• Western Infectious Disease Consultants — Denver, Colorado, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• McDowell Healthcare Center — Denver, Colorado, United States
• Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit — New Haven, Connecticut, United States
• Veterans Administration Medical Center — New Haven, Connecticut, United States
• Christiana Care Health Services HIV Program George — Wilmington, Delaware, United States
• Timothy A Price — Washington D.C., District of Columbia, United States
• George Washington Univ — Washington D.C., District of Columbia, United States
• Washington Reg AIDS Prog / Dept of Infect Dis — Washington D.C., District of Columbia, United States
• Miami Veterans Affairs Med Ctr — Miami, Florida, United States
• Center for Prevention and Treatment of Infections — Pensacola, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States
• Absolute Care Clinic — Atlanta, Georgia, United States
• AID Atlanta/Morehouse Med School Ryan White Cl — Atlanta, Georgia, United States
• AIDS Research Consortium of Atlanta (ARCA) Central — Atlanta, Georgia, United States
• Cobb-Douglas County Infectious Disease Clinic — Atlanta, Georgia, United States
• Dekalb County Health Dept Infectious Disease — Atlanta, Georgia, United States
• Kaiser Permanente-Fremont/Hayward Medical Centers — Fremont, California, United States

Full record on ClinicalTrials.gov

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