Criteria for U.S. Program.The U.S. program will make tenorovir Dr available to patients at least 18 years of age with HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. infection who have had a CD4 count CD4 count n. A measure of the number of helper T cells per cubic millimeter of blood, used to analyze the prognosis of patients infected with HIV. less than or equal to 100 cells/mm3 and an HIV RNA HIV RNA AIDS RNA of HIV origin, a serum marker of a Pt's 'HIV-ness,' now the standard by which Pt response to antiretovirals is evaluated; HIV RNA levels correlate with CD4+ count, response to antiviral therapy, clinical stage and disease progression. level of greater than or equal to 10,000 copies/mL by PCR PCR polymerase chain reaction. PCR abbr. polymerase chain reaction Polymerase chain reaction (PCR) within the past two months. Patients must also have failed treatment with at least two protease inhibitors (PIs) or one PI and one non nucleoside analog reverse transcriptase inhibitor nucleoside analog reverse transcriptase inhibitor NRTI, NARTI, "nuke" AIDS A class of drugs that includes AZT–Retrovir, ddI–Videx, ddC–HIVID, d4T–Zerit, 3TC–Epivir, abacavir–Ziagen; reverse transcriptase is the part of . Additionally, patients with a CD4 cell count between 100 cells/mm3 and 200 cells/mm3 and an AIDS-defining opportunistic infection within the last 90 days may also be eligible." "Physicians will be required to evaluate patients at baseline and after one month on therapy, then every two months until drug discontinuation or study termination following the protocol guide lines. Data collection is limited to the report of serious adverse events, and no specific laboratory testing is required except as indicated for standard medical care." The drug is taken as one pill per day - and patients should also be taking at least one other new antiretroviral. Phase III Results On February 20 Gilead released 24-week results from the ongoing phase III trial in treatment experienced patients. Those randomly assigned to tenofovir had a 0.6 log decrease in viral load, compared to a negligible change in those taking placebo. Both the tenofovir and placebo arms had the same dropout (1) On magnetic media, a bit that has lost its strength due to a surface defect or recording malfunction. If the bit is in an audio or video file, it might be detected by the error correction circuitry and either corrected or not, but if not, it is often not noticed by the human rate, 6% - indicating a good safety profile at the 24-week time point. (This trial will run for 48 weeks.) The drug is also being tested in a separate phase III trial in treatment-naive patients. |
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