| ACTG 5241 FACT SHEET |
| The Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen. (ACTG 5241, Version 1.0)
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Purpose of This Trial:
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| This study will determine if adding nucleoside analogue reverse transcriptase inhibitors (NRTIs) to a novel antiretroviral regimen for volunteers who are triple-class antiretroviral-experienced or resistant is beneficial.
Two strategies will be evaluated: 1) including or not including NRTIs in a new regimen and 2) the use of continuous phenotype susceptibility (cPSS) score to help choose study regimens. The treatment response will then be observed.
The study will make available several new drugs, including raltegravir, darunavir, tipranavir, etravirine, enfuvirtide and, if a subject has R5-tropic HIV, maraviroc.
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Requirements to Enter Study: |
- HIV infected people at least 16 years of age
- HIV viral load (HIV level) currently 1000 copies/mL or higher
- Currently on an HIV drug regimen that includes a protease inhibitor (PI)
- Have resistance to multiple types of HIV medications
- Had exposure to multiple types of HIV medications
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| Medications While on Study:
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Part 1 – Continue Current Medications
- Genotype/phenotype/ tropism assays performed – these tests determine what HIV medications would be effective
- A regimen is identified with a sum of at least 2 active mediations
- Study clinician, primary health care provider, and volunteer select study regimen and NRTIs from among options identified
Part 2 - New Study Regimen
- Randomization if cPSS >2.0 ( greater than 2 active HIV medications)
- Arm A: Study Regimen plus NRTIs for 48 weeks
- Arm B: Study Regimen without NRTIs for 48 weeks
- Registration if cPSS ≤2.0 (Observational Arm)
- Arm C: Study Regimen plus NRTIs for 48 weeks
- Up to 100 subjects may be enrolled
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| Length of Study: |
| Step 1: 2 months. Step 2: 12 months, totaling 14 months.
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Schedule of Study Appointments (about 1 hour each): |
Screening, Part 2 pre-entry, Part 2 entry and then at weeks 1, 4, 8, 12, 16, 24, 36 and 48. Visits include physical exams and blood draws.
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| Reimbursement: |
| Exams and lab tests are provided at no cost. The following HIV drugs will be provided through the study: enfuvirtide, raltegravir, darunavir, tipranavir, etravirine and maraviroc. (Which of these drugs are recommended for you depends on the results of the testing done in the Step 1 of the study.) Although they may be required or recommended by the study clinician, NRTIs and ritonavir will not be provided through the study; you will have to get these on your own. $20.00 per study visit.
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Contact: |
| The Screening Nurse at (206) 744-3184 |
