Protocol Number: 01-I-0004
Patients 18 years of age and older with HIV infection and viral levels between 5000 and 100,000 copies per milliliter of blood who have been taking antiretroviral therapy for at least 6 months may be eligible for this study. Candidates will be screened with a urine test and various blood tests, including genotyping and phenotyping. Participants will have a series of tests to determine whether or not a drug is active against HIV. This involves temporarily stopping the drug under study (i.e., either efavirenz or didanosine or stavudine). The study procedure is as follows: 1. Patients will have six blood tests over 10 days to measure viral load while on all current anti-HIV medications. On one of those days two blood tests will be done to measure levels of didanosine or stavudine. Efavirenz will also be measured if this drug is to be stopped. 2. The patient will temporarily stop the drug under while continuing to take the other drugs. (Efavirenz will be stopped for 3 weeks; stavudine and didanosine will be stopped for 2 weeks.) Seven blood tests will be done at the following intervals to measure viral load: For patients who stop efavirenz, blood will be drawn on days 13, 18, 20, 22, 24,28 and 30. (Day 0 is the first day of the study.) Patients who stop stavudine or didanosine will have blood drawn on days 11, 13, 15, 17, 19, 22 and 24. Repeat genotype and phenotype testing will also be done during this time, and a CD4 count (measurement of a certain type of white blood cell) will be done at the end of this 2- or 3-week period. 3. The drug that was stopped will be restarted and viral load tests will be repeated. For patients who stopped efavirenz, viral loads will be tested on days 34, 38, 40, 42, 44, 46, 49 and 52 of the study. Those who restart stavudine or didanosine will be tested on days 26, 28, 30, 32, 34, 36 and 38. Genotype and phenotype tests and a DC4 count will be repeated at the end of this period. The study is completed after the above procedures. However, for patients whose doctors suggest stopping their medications before beginning a new regimen, additional blood samples will be requested to measure viral load while the patient is off all drugs. Blood samples will be drawn on days 2, 7, 14 and 21 after stopping the drugs, or, alternatively, daily for 7 days and then weekly for 3 weeks.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/17/2009
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