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| |  ICAAC: Crixivan (Indinavir)/Ritonavir Combo Markedly Suppresses Viral Levels In HIV TORONTO, ON -- September 19, 2000 -- Preliminary study results showed Crixivan® (indinavir sulfate) administered as an investigational twice-daily 800-mg dose with a low dose of ritonavir (100 mg) suppressed levels of HIV to below the limits of detection in patients with no prior protease inhibitor (PI) experience. After 24 weeks of treatment, the viral levels of 93 percent of patients (26 of 28 for whom data was available) were reduced to below 400 copies/mL and 79 percent (22 of 28) reached viral levels below 50 copies/mL. The results were presented at the 40th meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). "These preliminary results, although in a small number of patients, are very encouraging in two ways. First, the twice-daily combination of Crixivan with low dose ritonavir reduced viral levels in protease inhibitor-naïve patients," said one of the study's lead investigators, Dr. Mark Watkins, a physician in private practice in Philadelphia. "Plus, the combination was generally well-tolerated with no food restrictions." Crixivan in combination with other antiretroviral agents is indicated for the treatment of HIV infection. The recommended 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 viral levels. This open-label, non-comparative, 24-week study of Crixivan (800 mg) combined twice-daily with a low dose of ritonavir (100 mg) enrolled 89 patients and was designed to evaluate efficacy and safety. The ethnically diverse patient population was comprised of 32 percent African-Americans, 20 percent Hispanic and Latinos, and 48 percent Caucasians. Women represented more than 20 percent of enrollees. Study participants had not been previously treated with a protease inhibitor and had viral levels of 5,000 copies/mL or greater. They received a regimen of Crixivan (800 mg) and ritonavir (100 mg) with 3TC and d4T administered twice daily. The preliminary results are based on data available from 28 patients who had completed 24 weeks of therapy at the time of the analysis. The study has been extended for an additional 24 weeks. The twice-daily regimen of Crixivan and ritonavir was generally well tolerated in the study. Six of the 89 patients enrolled (6.7 percent) discontinued therapy due to a drug-related adverse event. Nephrolithiasis was seen in 15 patients (16.9 percent), only three of whom (3.3 percent) discontinued therapy. The incidence of nephrolithiasis has been reported as approximately 9.3 percent in patients receiving Crixivan in clinical trials at the recommended dosage (800 mg q8h). An analysis of 20 of the 28 patients who completed 24 weeks of the study showed a modest increase in fasting serum triglyceride and cholesterol levels. At baseline, the median triglyceride level of the patient subset was 122 mg/dL. By week 24, the median level had increased to 153 mg/dL. Similar increases in fasting cholesterol levels were observed, from a median of 162 mg/dL at baseline to a median of 211 mg/dL at week 24. "These changes in lipid levels did not result in the addition of lipid lowering medications," said Dr. Watkins. 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 (terfenadine), Propulsid (cisapride), Hismanal (astemizole), Halcion (triazolam), Versed (midasolam), Orap (pimozide) or ergot derivatives such as Wigraine and Cafergot. Taking Crixivan with the above medications could result in serious or life-threatening problems (such as irregular heartbeat or excessive sleepiness). There are side effects associated with Crixivan. 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 is recommended for reducing 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". Concomitant use of Crixivan and St. John's wort (hypericum perforatum) has been shown to substantially decrease concentrations of Crixivan.
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