| ACTG 5126 FACT SHEET |
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A STUDY OF THE RELATIONSHIPS BETWEEN PROTEASE INHIBITOR (PI) DRUG LEVELS, RESISTANCE TESTS, AND ANTIVIRAL ACTIVITY IN SUBJECTS SWITCHING ANTI-HIV TREATMENT
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Purpose of This Trial:
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| This study will look at the relationship between the drug levels of three protease inhibitors (PIs), resistance test results, and short-term antiretroviral activity (from start of study to week 2). The PIs will each be given with ritonavir to increase their levels. The study will also look at these relationships over 24 weeks.
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| Requirements to Enter Study: |
- HIV positive
- Past treatment with 3 drug classes (NRTIs, NNRTIs, and PIs)
- No changes in current anti-HIV drugs for 90 days
- Currently taking 1, 2, or 3 PIs
- 13 years of age or older, men and women (women must not be pregnant.)
- HIV RNA (viral load) greater than 2,500 copies/ml
- Evidence of PI resistance
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| Medications While on Study: |
| One of the following PI combinations, (supplied by the study) will be chosen by the subject, with the help of the study clinician and the subject’s health care provider:
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Fosamprenavir (Lexiva™), is a form of amprenavir recently approved by the Food and Drug Administration that requires fewer pills.
For the first 14 days, subjects will stay on the non-PI drugs they have been taking. At day 15, subjects will start taking Tenofovir disoproxil fumarate (Viread™) (supplied by the study) and can change their background non-PI anti-HIV drugs.
If abacavir sulfate (Ziagen®), lamivudine(Epivir®), and/or zidovudine (Retrovir®)are chosen as a part of the background non-PI anti-HIV drugs, these will be supplied until the end of participation in the study.
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| Length of Study: |
| 24 weeks. |
| Schedule of Study Appointments (about 1 hour each) |
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Screening, pre-entry, entry and weeks 1, 2, 4, 8, 16, and 24. Visits include physical exams, and blood draws for safety and efficacy lab tests. The 2-week visit requires one 13-hour visit.
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| Reimbursement: |
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Exams, lab tests, and the study drugs are provided at no cost. Subjects will receive $20 per study visit, and $100 for the full day visit at week 2.
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| Contact: |
| Margot Perrin or Lori Cray at 731-3184 |
