[Federal Register Volume 65, Number 249 (Wednesday, December 27, 2000)]
[Notices]
[Pages 81874-81875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Antiviral Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Antiviral Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on January 11, 2001, 8:30
a.m. to 5:30 p.m. Interested persons and organizations may submit
written comments by January 8, 2001, to the Dockets Management Branch
(address below).
Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave.,
Bethesda, MD. Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Contact Person: Tara P. Turner, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, e-mail: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12531. Please call the Information Line for up-to-date
information on this meeting.
Agenda: Presentations and committee discussions will focus on
clinical trial design issues for patients with human immunodeficiency
virus (HIV-1) infection who have limited therapeutic options (treatment
sometimes referred to as ``salvage'' therapy). This meeting is being
convened in response to the recognized difficulty in evaluating the
safety and effectiveness of new antiretroviral therapeutics in heavily
pretreated patients. A further goal of this meeting is to facilitate
and promote the development of new therapies for patients who are most
in need of new therapeutic options.
For the purpose of this meeting, we will define ``salvage'' therapy
as regimens that follow a loss or lack of virologic response to at
least two previous antiretroviral regimens that, in total, have
consisted of drugs from all of the approved drug classes (protease
inhibitors, nucleoside and non-nucleoside reverse transcriptase
inhibitors). This population of heavily pretreated patients reflects a
population for whom selection of active controls in clinical trials is
a particular challenge.
The primary objectives for the committee deliberations are to
discuss issues relating to the identification of appropriate control
arms, possible trial designs, and study endpoints for this patient
population. In order to prepare presentations and discussions for the
meeting, the agency is requesting interested persons to submit in
writing the following types of relevant data, information, and views:
1. Proposals for trial designs, including comments and suggestions
on the following:
The role of intensification trials, concentration
controlled trials, historical-controlled trials, dose-response trials,
and factorial comparisons using multiple investigational agents;
Blinded versus open label trials;
Study duration or duration of blinded treatment; and
Pertinent statistical considerations for different trial
design options.
2. Comments relating to patient population inclusion criteria and
suggestions for baseline stratification characteristics (such as
treatment history, resistance testing, CDC classification or others).
3. Proposals and comments regarding appropriate control arms and
the role of resistance testing for constructing treatment regimens.
4. Comments on appropriate outcome measures such as virologic and/
or
[[Page 81875]]
clinical endpoints for trials in heavily pretreated patients.
5. Comments on any additional considerations for clinical trials in
treatment experienced pediatric patients.
These submissions should contain docket number 00N-1585, and they
should be made to the Dockets Management Branch address provided
previously in this document.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by January 4,
2001. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before January 4, 2001, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-32889 Filed 12-26-00; 8:45 am]
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