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5303 FACT SHEET
A Phase 2b,Double-Blind,Placebo-Controlled,Exploratory randomized Trial to Determine the Bone, Immunologic, Virologic, and Neurocognitive Effects of a Novel Maraviroc-Containing Antiretroviral Regimen in Treatment Naïve Patients Infected withR5-Tropic HIV-1(ACTG 5303)
Purpose of This Trial:
To determine if an investigational HIV treatment regimen containing darunavir, ritonavir, emtricitabine, and maraviroc results in less bone density loss compared to a regimen of darunavir, ritonavir, emtricitabine, and tenofovir.

You may be eligible if you are:
  • Are an HIV positive man or woman, age 18 or older
  • Have never taken HIV medications
  • Have an HIV viral load greater than 1,000
  • Have a certain type of HIV called “R5” - based on trofile testing
  • Do not have resistance to medications used in the study
  • Agree to neuropsychological testing
  • Do not have an active Hepatitis B infection
  • Are not pregnant, breast feeding, or planning pregnancy
  • Have not started any hormonal therapies in the last 6 months
  • Have not started oral contraceptives within 3 months
  • Weigh less than 300 pounds
  • Have not broken a bone because your bones are weak
Medications While On Study:
All study medications will be provided at no cost
Length of Study:
About 48 weeks
Schedule of Study Appointments:
Screening, Pre-Entry, Entry, and Weeks 4, 16, 24, 36 and 48. Dual-energy X-ray absorptiometry (DXA) scans will be performed at entry and weeks 48.
Reimbursement:
Clinical exams, lab tests, and DXAs are provided at no cost. You will receive $20 per visit starting at entry, $25 for each DXA, and $10 for each neuropsychological test.
Contact:
The ACTU Screening Nurse at 206-744-3184.
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© University of Washington AIDS Clinical Trial Unit, updated 08/09/2012.