A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers.
(The ARDENT Study: Atazanavir, Raltegravir, or Darunavir with Emtricitabine/Tenofovir for Naïve Treatment)
The purpose of this study is to compare the effectiveness and tolerability of three combination FDA-approved HIV medication regimens using Truvada (emtricitabine/tenofovir disoproxil fumarate) as a base along with:
- Group A=Reyataz (atazanavir) and Norvir (ritonavir)
- Group B=Isentress (raltegravir)
- Group C=Prezista (darunavir) and Norvir (ritonavir)
Medications are open label.
All medications will be provided except Norvir; but the co-pay for Norvir will be reimbursed with receipt.
You will be in this study between 96 weeks and 192 weeks depending on when you join.
About 1,800 people will take part in this study. We anticipate enrolling about 40 subjects for this study at Rush.
In order to participate you must:
- Be HIV positive
- Have never taken HIV medication (exceptions are for pregnancy and post exposure prophylaxis)
- Have an HIV viral load greater than or equal to 1,000 copies/ml within 90 days
- Have HIV genotype test results
- Be able to get Norvir with a prescription
You will be not be able to be in the study if you:
- Have HIV mutations to the study drugs
- Are pregnant or breast feeding
- Used entecavir for hepatitis B treatment for over eight weeks while HIV positive
- Have decompensated cirrhosis of the liver