|
|
|
FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA
Human Immunodeficiency
Virus and
Acquired Immunodeficiency Syndrome
For up-to-date information about upcoming FDA Advisory Committee meetings, please use the FDA Advisory Committe Information Line. The service provides recorded messages with date, location, and topic information about upcoming meetings.
to search for other topics and resources
Viewing Files Some of these documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the free Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's Website with full installation instructions.
Microsoft Word files can be viewed with that application or with a free, downloadable document viewer available from the Microsoft Website. If you need additional information about viewing these types of files, go to General Help for Accessing Files.
Date: September 23, 2004
Committee: Vaccines and Related Biological Products Advisory Committee
Topic: Review of Thailand HIV vaccine phase III trial for an HIV I recombinant
canarypox-vectored vaccine and a recombinant gp 120 B/E CHO cells with alum
vaccine.
Date: March 25, 2004
Committee: General and Plastic Surgery Devices Panel (Center for Devices and
Radiological Health) Topic: Premarket approval application (PMA) for an injectable
device intended for use in the correction of lipoatrophy of the face in human
immunodeficiency virus (HIV) positive patients (Dermik Laboratories) (Poly L-
Lactic Acid, Sculptra, also known in Europe as New Fill).
Date: August 20, 2003
Committee: Antiviral Drugs Advisory Committee
Topic: Clinical trial design issues in the development of topical
microbicides for the reduction of HIV transmission.
Date: May 13-14, 2003
Committee: Antiviral Drugs Advisory Committee
Topic: Reyataz™ (atazanavir sulfate) capsules, new drug application (NDA)
21-567, (Bristol-Myers Squibb Company), for the treatment of human immunodeficiency
virus infection.
Date: May 14, 2003
Date March 3, 2003
Committee: Anti-Infective Drugs Advisory Committee, Pediatric Subcommittee
Topic: Issues related to the development of antiretroviral drugs in human
immunodeficiency virus (HIV)-infected and HIV-exposed neonates younger than
4 weeks of age
There were no FDA advisory committee meetings directly related to HIV/AIDS during 2002
Date 10/24 - 25/01
Committee: Biological Response Modifiers Advisory Committee
Topic: Lentiviral vector gene transfer product for treatment
of people with HIV
Date: 10/3/01
Committee: Antiviral Drugs Advisory Committee
Topic: Viread™ (tenofovir disoproxil fumarate) Tablets, new drug application
(NDA) 21-356 (Gilead Sciences) for the treatment of human immunodeficiency virus
(HIV) infection,
Date: 2/27/01 Committee: Antiviral Drugs Advisory Committee
Topic: Valcyte (valganciclovir hydrochloride) tablets, 450mg, Syntex (USA) LLC,
NDA 21-304, proposed for treatment of cytomegalovirus (CMV) retinitis in patients
with acquired immunodeficiency syndrome (AIDS).
Date: 01/11/01
Committee: Antiviral Drugs Advisory Committee
Topic: Clinical trial design issues for patients with HIV-1 infection who have
limited therapeutic options
Date: 10/16/00
Committee: Antiviral Drugs Advisory Committee
Topic: The use of surrogate markers in early development of
immunomodulatory agents for the treatment of patients with HIV.
Date: 9/14/00
Committee: Blood Products Advisory Committee
Topic: FDA blood or plasma donor deferral policy related to men who have had
sex with men (MSMs) ~ Blood Donor Deferral for MSMs
Date: 7/25/00
Committee: Antiviral Drugs Advisory Committee
Topic: The role of pharmacokinetic data in the evaluation of new formulations,
alternative dosing regimens and new dosing combinations of approved antiretroviral
drugs.
Date: 11/2/99-11/3/99
Committee: Antiviral Drugs Advisory Committee
Topic: The role of genotypic and phenotypic HIV resistance testing in antiretroviral
drug development
Date 11/1/99
Committee: Antiviral Drugs Advisory Committee
Topic: Adefovir, new drug application (NDA) 20- 993, adefovir dipivoxil (Gilead
Sciences Inc.), for the treatment of human immunodeficiency virus infection.
Date: 10/4/99
Committee: Antiviral Drugs Advisory Committee
Topic: Discussion of issues related to the potential applicability of information
from non-U.S. studies of prevention of perinatal human imunodeficiency virus
transmission to U.S. clinical settings.
Date: 09/17/99
Committee: Blood Products Advisory Committee
Topic: Reclassification of Human Immunodeficiency Virus (HIV)
drug sensitivity assays. The agency described the general classification of
biological products, and asked the committee for a recommendation for classification
of viral resistance assays. The classification assignment determines how these
assays are regulated by the agency.
Date: 11/2/98
Committee: Antiviral Drugs Advisory Committee
Topic: Ziagen (abacavir sulfate), new drug application (NDA) 20-977/20-978 to
treat HIV infection
Transcript (Rich Text
Format)
Transcript (PDF - 166
KB)
Date: 7/14/98
Committee: Antiviral Drugs Advisory Committee
Topic: Presentations on general regulatory procedures and policies, including
overview of the Food and Drug Administration Modernization Act of 1997
Transcript (PDF- 4 MB)
Date: 5/6/98
Committee: Antiviral Drugs Advisory Committee
Topic: NTZ (nitazoxanide), new drug application (NDA) 20-871 for treatment of
Cryptosporidiosis
Transcript (Rich Text
Format)
Transcript (PDF - 12
MB)
Date: 7/14/97-7/15/97
Committee: Antiviral Drugs Advisory Committee
Topic: Utility of plasma HIV RNA as an endpoint in clinical trials for drugs
to treat HIV infection, and review of pediatric HIV data
Transcript (PDF
Format - 12 MB)
Additional Document: Summary
Minutes
Date: 6/23/97
Committee: Oncologic Drugs Advisory Committee
Topic: Zyrkamine (mitoguazone dihydrochloride, ILEX Oncology), indicated for
treatment of AIDS-related non-Hodgkins lymphoma in patients who have been previously
treated with at least one potentially curative regimen.
Transcript (Rich Text
Format)
Transcript (PDF)
Additional Documents: Slides,
Part 1, Slides, Part 2
Transcripts from 1996 meetings are available from the Freedom of Information Office.
Date: 11/22/96
Committee: Antiviral Drugs Advisory Committee
Topic: Rescriptor (delavirdine), new drug application (NDA) 20-705 for the treatment
of HIV infection
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Date: 11/20-22/96
Committee: Joint meeting of the Nonprescription Drugs Advisory Committee, the
Antiviral Drugs Advisory Committee, the Anti-Infective Drugs Advisory Committee
and the Advisory Committee for Reproductive Health
Topic: The use of microbicidal topical vaginal agents against sexually transmitted
chlamydia trachomatis and Neisseria gonorrhoeae. Discussion on guidelines for
the development of vaginal products for preventing the transmission of HIV.
Discussion on proposals and guidances for clinical efficacy studies on marketed
OTC vaginal spermicides.
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Date: 6/7/96
Committee: Antiviral Drugs Advisory Committee
Topic: Viramune (nevirapine), new drug application (NDA) 20-636 for the treatment
of HIV infection
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Date: 3/15/96
Committee: Antiviral Drugs Advisory Committee joint meeting with Ophthalmic
Drugs Subcommittee
Topic: Vistide (cidofovir, intravenous), new drug application (NDA) 20-638 for
the treatment of CMV retinitis
Summary Minutes
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Date: 3/1/96
Committee: Endocrinologic and Metabolic Drugs Advisory Committee joint meeting
with Antiviral Drugs Advisory Committee
Topic: Serostim (somatropin), new drug application (NDA) 20-604 for the treatment
of AIDS wasting or cachexia
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Date: 3/1/96
Committee: Antiviral Drugs Advisory Committee
Topic: Crixivan (indinavir capsules), new drug application (NDA) 20-685 for
the treatement of HIV infection
Transcripts from 1996 meetings are available
from the Freedom of Information
Office.
Date: 2/29/96
Committee: Antiviral Drugs Advisory Committee
Topic: Norvir (ritonavir), new drug application (NDA) 20-659/20-68
for the treatement of HIV infection
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Date: 2/28/96
Committee: Antiviral Drugs Advisory Committee
Topic: Retrovir (zidovudine), new drug application (NDA) 19-665/19-919
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Date: 2/28/96
Committee: Antiviral Drugs Advisory Committee
Topic: Discussion of recent studies with nucleoside analogues for the treatment
of HIV infection. Data from AIDS Clinical Trials Group (ACTG) Study 175, the
Delta studies, and other relevant studies. Data from Videx new drug application
(NDA) 20-154, 20-155 and 20-156, Retrovir NDA 19-655 and 19-910 and HIVID NDA
20-199 were discussed. Transcripts from 1996 meetings are available from the
Freedom of Information Office.