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HIV and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome

Advisory Committee Meetings related to HIV/AIDS
and associated conditions

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.

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2004

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).

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2003

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

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2002

There were no FDA advisory committee meetings directly related to HIV/AIDS during 2002


2001

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

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2000

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.

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1999

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.

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1998

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)

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1997

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

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1996

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.

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