| 5257 FACT SHEET |
| A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers (ACTG 5257)
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Purpose of This Trial:
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| This study will compare three different antiretroviral (ARV) regimens in people who have not taken ARVs before.
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Requirements to Enter Study: |
- HIV-positive men and women 18 years or older
- Viral load more than 1000 copies/ml
- No major HIV resistance mutations
- Have not taken ARVs (for more than 9 days)
- Lab tests within certain limits
- Negative pregnancy test for women and use of contraception
- Need to take a medication not allowed on the study
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| Medications While On Study: |
At entry you will be randomly assigned (like flipping a coin) to one of three treatment groups. The treatment groups are:
Group 1: Atazanavir (ATV) 300 mg once daily (QD) + ritonavir (RTV) 100 mg QD + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) 200/300 QD
Group 2: Raltegravir (RAL) 400 mg twice daily (BID) + FTC/TDF 200/300 mg QD
Group 3: Darunavir (DRV) 800 mg QD + RTV 100 mg QD + FTC/TDF 200/300
All study drugs will be provided without cost except ritonavir
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| Length of Study: |
| 96 weeks from the last enrollment (estimated to be a maximum of 192 weeks).
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Schedule of Study Appointments (about 1 hour each): |
Screening, pre-entry, entry and at weeks 2, 4, 8, 16, 24, 36, 48, 63, 80, and 96), plus additional visits every 16 weeks thereafter until the study ends. Visits include physical exams and blood draws.
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Metabolic Substudy: |
This substudy will include tests to investigate how the study drugs affect fat deposits in blood vessels and the abdomen. These tests include: computer tomography (CT) scans, ultrasounds of the carotid arteries (CIMT), tests of an artery in the arm (FMD), and dual x-ray absorptiometry (DEXA).
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| Reimbursement: |
| $20 per study visit.
For Substudy: CT scan $15, CIMT $15, FMD $15, and DEXA $15 per test
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Contact: |
The Screening Nurse at 206-744-3184.
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