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



Executive Summary

The National Institute of Allergy & Infectious Diseases should develop a comprehensive plan of research on HIV opportunistic infections and outline what information is required for the planning process, the House Government Operations Committee recommends in a report released Dec. 2. Entitled "Obstacles to Drug Development for HIV-Related Opportunistic Infections," the report notes that NIAID has developed a draft plan for HIV-related research as part of its long-term strategic plan that broadly notes research goals in several areas, such as epidemiology and vaccines. However, the committee report says the plan does not include future needs for staffing and funding, research priorities, "or information to support NIAID's selection of [opportunistic infections] on which to focus research efforts." In March, the Institute of Medicine called for NIH to develop a five-year plan. At the request of Rep. Weiss' (D-N.Y.) Government Operations/Intergovernmental Relations Subcommittee, NIAID submitted the draft plan dated May 1990. The committee report lists seven areas in which further information is needed for the research plan: (1) the incidence of the opportunistic infection in the various population groups; (2) the stage of HIV disease progression in which each opportunistic infection is most likely to occur; (3) the degree of threat to the life of the patient for each opportunistic infection; (4) therapies now available for each opportunistic infection; (5) therapies now in the pipeline and when they are anticipated to be available for clinical trials; (6) projections of which opportunistic infections will be most prevalent in coming years and what therapies will be needed; and (7) the role of the private sector versus the federal government in the development of these therapies. "The committee believes that a plan with detailed goals and activities, timetables and costs must be developed by NIAID for improving the balance between opportunistic infection research and antiretroviral research against which progress can be measured," the report states. The committee argued that research on opportunistic infections has suffered because of the high priority given to antiretroviral research. The report notes that in September 1991, "21% of all patients enrolled in ACTG [AIDS Clinical Trials Group] trials were in [opportunistic infection] protocols" and one study evaluating three regimens for primary prevention of pneumocystic carinii pneumonia "accounted for 38% of the total patient population in all OI studies." As of September, the committee said, OI studies accounted for 28% of all clinical trials. The committee recommended that when the 32 adult AIDS Clinical Trials Units (ACTUs) that comprise the ACTG come up for renewal in 1992, NIAID should consider the extent of their participation in protocols for OI studies. The report says that at the time of the subcommittee's August 1990 hearing, only 23 of the 32 adult ACTUs had participated in acute OI studies. The report highlights the efforts of the University of Southern California (USC) Medical Center, noting that it has enrolled the largest number of patients in OI trials (295) and has the largest number of inpatients in OI trials. NIAID's ACTG protocol 175 studying combinations of antiretrovirals illustrates the need for a comprehensive research plan, the committee argued. The proposed protocol has four treatment arms: AZT 200 mg tid; AZT 200 mg tid/ddI 220 mg bid; AZT 200 mg tid/ddC 0.75 mg tid; and ddI 200 mg bid. The enrollment goal is 2,100 patients (525 per arm); the protocol will be open to all ACTUs in late January or early February 1992. The estimated cost of the study is approximately $ 21 mil. over three years. The committee observed that the 1992 budget for ACTUs is $ 48 mil. Among other recommendations, the committee report urges the Health Care Financing Administration to reassess its policy for reimbursement of experimental state-of-the-art treatments.

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




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