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| |  CROI: Crixivan/ZDV/3TC Combo Suppresses Viral Loads In Early HIV SAN FRANCISCO, CA -- February 7, 2000 -- A new retrospective analysis showed that a greater proportion of HIV infected patients treated early with a combination including Crixivan(R) (indinavir sulfate), ZDV (zidovudine) and 3TC (lamivudine) achieved durable suppression of viral levels below the limit of detection (less than 500 copies/mL) and increased CD4 cell counts compared to patients starting treatment in the later disease stages.
In addition, the analysis showed that treatment with Crixivan in combination resulted in durable viral suppression in all patients studied, including those recently infected to those in late stages of HIV disease. These findings are based on a 48-week follow-up of an ongoing clinical study in early disease (Protocol 060) and a separate retrospective analysis of four clinical studies (including Protocol 060) which were conducted by Merck & Co., Inc. The new analysis was presented at the 7th Annual Conference on Retroviruses and Opportunistic Infections. "In our analysis, we saw that viral load levels were reduced and CD4 cell counts elevated as a result of earlier treatment with the regimens containing Crixivan," said Dr. Michael Robertson, associate director, clinical research, Merck Research Laboratories and a study co-author. "Although our research showed marked responses across all stages of HIV disease, a greater proportion of patients who initiated antiretroviral therapy with a regimen including Crixivan sooner -- such as those in the acute infection and early disease groups -- were below the limit of detection. Even patients with more advanced disease had a good antiretroviral response, such as suppression of viral RNA (vRNA) and increased CD4 cell counts, with these regimens. Regardless of the stage of disease, regimens with Crixivan consistently demonstrated potent antiviral response." Crixivan in combination with other antiretroviral agents is indicated for the treatment of HIV infection. The dosage of Crixivan is 800 mg every eight hours. The indication for Crixivan is based on two clinical trials of approximately one-year duration that demonstrated a reduction in the risk of AIDS-defining illnesses or death and a prolonged suppression of HIV RNA. Merck researchers analyzed 48-week data from four clinical studies (studies 042, 060, 035 and 039, respectively) of patients treated with Crixivan 800 mg every eight hours, ZDV (600 mg total dosed either twice or three times daily) and 3TC (150 mg dosed twice-daily). Studies included patients from various stages of disease, including acute infection (47 newly infected patients), early (199 patients with greater than or equal to 500 CD4 cells/mm3 and vRNA greater than 1,000 copies/mL), moderate (33 patients with 50 to 400 CD4 cells/mm3 and vRNA greater than or equal to 20,000 copies/mL)and late-stage infection (108 patients with less than or equal to 50 CD4 cells/mm3 with any measurable vRNA). The purpose of the studies was to evaluate the CD4 and HIV RNA responses. The intent-to-treat analysis found that a greater proportion of patients achieved durable viral load suppression (viral levels below 500 copies/mL) when therapy was started earlier in the HIV disease lifecycle. Specifically, 90 percent of patients with acute infection, 83 percent of patients in early stage infection, 80 percent of patients with moderate infection, and 52 percent of patients in late-stage disease were below detection. In addition, significant increases in CD4 cell counts were observed in all patient groups, even in patients with later stages of disease. "Our analysis offers further insights into the effects of boosting CD4 cell count and reducing viral levels early in the disease," Robertson said. "It is particularly meaningful because we're at a turning point in the way clinicians are approaching the fight against AIDS." Crixivan can be taken with a light meal or on an empty stomach. There are some common and AIDS-related medications that should not be taken with Crixivan. Crixivan should not be administered concurrently with Seldane(R) (terfenadine), Propulsid(R) (cisapride), Hismanal(R) (astemizole), Halcion(R) (triazolam), Versed(R) (midasolam), or ergot derivatives such as Wigraine(R) and Cafergot(R). Taking Crixivan with the above medications could result in serious or life-threatening problems (such as irregular heartbeat or excessive sleepiness). Crixivan is generally well tolerated. There are side effects associated with protease inhibitors in general and Crixivan in particular. Some patients treated with Crixivan may develop kidney stones. For some, this can lead to more severe kidney problems, including kidney failure. Drinking at least six glasses of water a day may help reduce the chance of forming a kidney stone. Other side effects that have been reported include liver problems and rapid breakdown of red blood cells. As with other protease inhibitors, changes in body fat, increased bleeding in some patients with hemophilia and increased blood sugar levels and diabetes have been reported and severe muscle pain and weakness have occurred in patients also taking cholesterol-lowering medicines called "statins." Related Links: Crixivan (indinavir sulfate), ZDV (zidovudine), 3TC (lamivudine) and Merck & Co., Inc.
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