To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ROI Conference: Crixivan In Triple Therapy Kept HIV Below Detection In Most Patients After Three Years URL: http://www.pslgroup.com/dg/E1E0E.htm Doctor's Guide February 5, 1999
WEST POINT, PA – Feb. 5, 1999 – Study results show that a regime of Merck & Co.'s Crixivan(R) (indinavir sulfate), AZT and 3TC suppressed circulating HIV levels to below detection (less than 50 copies/ml) in 63 percent (19 of 30) of patients from whom data was available for three years (156 weeks). Also, a separate analysis of samples taken from a subset of study patients found that residual virus could not be detected (less than 50 copies/ml) in the cerebrospinal fluid (CSF) or genital secretions after two years of treatment and that there was minimal evidence of ongoing virus replication in the lymph nodes -- three known hiding places of the virus. The data were presented this week's at the sixth conference on Retroviruses and Opportunistic Infections, marking the third anniversary of the study's initial presentation. "[The study] continues to suggest that long-term, durable suppression of HIV is possible in patients who begin treatment with a three-drug regimen containing a protease inhibitor," said Roy Gulick, M.D., assistant professor of medicine, Cornell University Medical College and the principal investigator of the study. Crixivan in combination with other antiretroviral agents is indicated for the treatment of HIV infection. The approved 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. The study is an ongoing study that included 97 AZT-experienced patients who had not been previously treated with 3TC or a protease inhibitor and had viral load levels of at least 20,000 copies/ml and CD4 cell counts between 50 to 400 cells/cubic mm. Patients were initially randomised to one of three regimens: Crixivan alone (800 mg every eight hours); AZT (200 mg every 12 hours) and 3TC (150 mg every 12 hours); or a combination of the three drugs. After at least 24 weeks of treatment, all patients were changed to open-label therapy with Crixivan, AZT plus 3TC. Of the 33 patients who began triple combination therapy at the start of the study, eight withdrew before week 156 for therapy-related reasons (for example adverse events, viral rebound) and three patients withdrew for reasons unrelated to the study therapy. Twenty-two of the original 33 patients in the Crixivan, AZT plus 3TC group remained in the study at three years. Based on an intent-to-treat analysis that included data from patients who discontinued due to therapy or who had HIV levels of more than 500 copies/ml, 68 percent of patients (21 of 31) who initiated the triple-drug combination simultaneously had undetectable blood levels of HIV (less than 500 copies/ml) and 63 percent (19 of 30) also had less than 50 copies/ml at week 156. In addition, CD4 cell counts increased by a median of 230 cells/cubic mm in 29 patients for whom data was available at week 156. A separate analysis of a subset of patients in the study who experienced long-term suppression of circulating virus found little evidence of residual virus in body compartments that likely support HIV replication. After two years of treatment, the analysis did not detect the virus (less than 50 copies/ml) in the cerebrospinal fluid of 15 studied patients, nor did it detect virus in the genital secretions of 20 out of 23 patients. In lymph node samples from 20 studied patients, some cells that exhibited evidence of HIV replication were seen. Drug related serious adverse events occurred in three patients, all of whom had nephrolithiasis. A total of 13 patients on treatment for up to three years had at least one episode of nephrolithiasis. In addition, four patients had lipodystrophy, according to a broad clinical definition of the term which is known as fat redistribution syndrome. Related Links: Crixivan, Merck --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.