Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

NIAID INCREASING AIDS OPPORTUNISTIC DISEASE PROTOCOLS BY 30%-40%

Executive Summary

NIAID INCREASING AIDS OPPORTUNISTIC DISEASE PROTOCOLS BY 30%-40% over the next year, National Institute of Allergy & Infectious Diseases Director Anthony Fauci, MD, told a May 14 Washington, D.C. "town forum" on AIDS sponsored by the Institute for Advanced Studies in Immunology and Aging. The increase represents 12 new protocols on opportunistic infections. Over the last 12 months, the number of NIAID studies on opportunistic diseases increased from 10% of all AIDS protocols to 20%, Fauci said. The number of participants in opportunistic studies increased from 600 to about 2,000 during this period. NIAID also plans to add six protocols on HIV infection over the next year. The opportunistic protocols are likely to be more expensive and more complicated than viral studies in which an asymptomatic patient can be treated with AZT, Fauci commented. "As soon as the hospital finds out that you want to do a protocol study on [a patient with an opportunistic infection], many hospitals will immediately withdraw third-party payment," Fauci observed. "So all of a sudden the protocol has to pay for it. Instead of costing $500 to $1,000 [per] patient, it's going to cost $15,000 to $20,000 depending on how sick the person is. This is something that needs to be addressed; that's beyond our control." NIAID also plans to increase the participation of intraveneous drug users in AIDS clinical trials to 20%, about equalling the percentage of drug users in the overall AIDS population, Fauci told the public forum. Currently, drug users represent about 10% of the total clinical trial population. Fauci was one of four clinical experts participating on the panel. Robert Gallo, MD, chief of the Laboratory of Tumor Cell Biology at the National Cancer Institute, was questioned about the "confidentiality agreement" between NCI and an unnamed Japanese pharmaceutical company to develop a drug to treat Kaposi's sarcoma. "We contacted this company and met with them," Gallo responded. "They had never collaborated with the United States Government before...only within pharmaceutical companies within Europe and Japan. They wanted a confidentiality agreement to get more of an idea of the drug" under investigation, he said, adding that NCI has completed "only the first stage of the study." George Washington University researcher Allen Goldstein, PhD, said the first phase of testing the AIDS vaccine HGP-30 in HIV-negative individuals is nearing completion. Results are expected to be presented at the International AIDS conference in San Francisco in June.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

OM013164

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel