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ACTG 5217 FACT SHEET
The SETPOINT Study – A Randomized Study of the Effect of Immediate Treatment with Potent Antiretroviral Therapy versus Observation with Treatment as Indicated in Newly Infected HIV-1-Infected Subjects: Does Early Therapy Alter the Virologic Setpoint?
Purpose of This Trial:
To compare the safety and effectiveness of 36 weeks of treatment versus no treatment.
Requirements to Enter Study:
  • Acquired HIV-1 infection within the past 6 months
  • HIV viral load at least 500 copies/ml
  • CD4 T cells at least 350 cells/mm3
  • No prior HIV treatment
  • No HIV progression to CDC category B or C disease
  • No history of pancreatitis
Study Design:

Randomized (like flipping a coin) to either:

  • Group A: Treatment with Emtricitabine/Tenofovir DF and Lopinavir/ritonavir (Kaletra) for 36 weeks (provided by study). If you are assigned to group A, you may also choose to take treatment other than Emtricitabine/Tenofovir DF, and Lopinavir/Ritonavir, but you would have to get these medications by prescriptions. These medications will not be provided by the study. After 36 weeks, participants will stop taking study medications.
or
  • Group B: No treatment (observation) unless needed because HIV disease is progressing

At any time during the study, participants who are not on anti-HIV drugs may be encouraged to begin or restart based on symptoms or lab test results.
Length of Study:
Up to 96 weeks
Schedule of Study Appointments (about 1 hour each):

Screening, pre-entry, entry and weeks 1, 2, 4, and then every 4 weeks. Visits include physical exams, blood draws, and questionnaires.

Reimbursement:
Exams, lab tests, and study medications are provided at no cost. Participants will receive $20 per study visit.
Contact:
Call 206-521-1978 and ask for Claire Stevens or Janine Maenza
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