AEGiS-ATN: Crixivan(R) (Indinavir): Three Doses Daily, Not Two, in Most Regimens

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Crixivan(R) (Indinavir): Three Doses Daily, Not Two, in Most Regimens

AIDS TREATMENT NEWS Issue #304, October 2, 1998
John S. James

On September 18 Merck & Co., Inc. announced that it had discontinued clinical trials with twice-daily dosing of indinavir (Crixivan) in combination with nucleoside analogs only. However, it is still continuing studies of twice-daily indinavir dosing in combination with protease inhibitors nelfinavir or ritonavir (which increase the time that indinavir stays in the bloodstream). The FDA-approved dosing of indinavir is every eight hours, but many patients had switched to twice daily after an earlier small trial had suggested that the two regimens might be equivalent.

The twice-daily dosing was discontinued after a new larger trial found that at 24 weeks, 91% of those on the approved three-times dosing regimen had a viral load below 400 copies, compared to only 64% of those with twice-daily dosing. A total of 87 patients had reached the 24-week time point and were included in this comparison. Besides the indinavir, participants in both treatment arms were taking AZT plus 3TC. They had not been treated with protease inhibitors, or with 3TC, before beginning this study.

Discontinuation rates were low and similar in both groups.

Also, there was a trend toward more discontinuation of the twice-daily regimen due to nausea and vomiting.

Persons using indinavir twice daily should promptly check with their physicians about options for modifying their treatment.

981002
ATN30402

Copyright © 1998 - AIDS Treatment News. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Subscription lists are kept confidential. AIDS Treatment News, Subscription and Editorial Office: 1233 Locust St., 5th floor Philadelphia, PA 19107 800/TREAT-1-2 toll-free email: aidsnews@critpath.org http://www.aidsnews.org

Subscription Information: Call 800/TREAT-1-2: Businesses, Institutions, Professionals: $270/year. Includes early delivery of an extra copy by email. Nonprofit organizations: $135/year. Includes early delivery of an extra copy by email. Individuals: $120/year, or $70 for six months. Special discount for persons with financial difficulties: $54/year, or $30 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1998. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .