FDA Advisory Committee Meetings related to HIV/AIDS and associated conditions

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HIV and AIDSHuman Immunodeficiency Virus andAcquired Immunodeficiency Syndrome

Advisory Committee Meetings related to HIV/AIDSand associated conditions

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Adefovir (adefovir dipivoxil) Blood Donor Deferral for MSMs Clinical trial design-limited therapeutic options Crixivan (indinavir) Endpoints & plasma HIV RNA

Genotypic & phenotypic HIV resistance testing HIV drug sensitivity assays Hivid (zalcitabine) Immunomodulatory agents & surrogate markers

Lentiviral vector gene therapy Neonates with HIV

Norvir (ritonavir) NTZ (nitazoxanide) Perinatal HIV transmission

Pharmacokinetic data & its role in evaluation of new formulations & dosing regimens Regulatory procedures & FDAMA overview Rescriptor (delavirdine) Retrovir (zidovudine) Reyataz (atazanavir) Sculptra (poly L-lactic acid) facial filler implant Serostim (somatropin) Topical microbicides & clinical trial design Vaginal topical microbicides - development of vaginal products for preventing the transmission of HIV Valcyte (valganciclovir) Videx (didanosine) Viramune (nevirapine) Viread (tenofovir) Vistide (cidofovir) Ziagen (abacavir) Zyrkamine (mitoguazone)

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2004

Date: March 25, 2004Committee: 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).

Notice of Meeting (PDF) (48 KB) March 25, 2004 Agenda (PDF - 70 KB) (Word) March 25, 2004 Panel Roster (PDF- 68KB) (Word) March 25, 2004 Briefing Information March 25, 2004 Slides March 25, 2004 Transcript (Word)

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2003

Date: August 20, 2003Committee: Antiviral Drugs Advisory Committee Topic: Clinical trial design issues in the development of topical microbicides for the reduction of HIV transmission.

Notice of Meeting (PDF -48KB) August 20, 2003 Final Agenda (PDF- 25KB) (Word) August 20, 2003 Draft Agenda (PDF - 51KB) (Word) August 20, 2003 Committee Roster (PDF - 101 KB) (Word) August 20, 2003 Guests/Consultants Roster (PDF - 78 KB) (Word) August 20, 2003 Final Questions (PDF - 79 KB) (Word) August 20, 2003 Draft Questions (PDF - 60 KB) (Word) August 20, 2003 Briefing Informaton August 20, 2003 Slides August 20, 2003 Transcript (PDF) (Word)

Date: May 13-14, 2003Committee: Antiviral Drugs Advisory Committee Topic: Reyatazâ„¢ (atazanavir sulfate) capsules, new drug application (NDA) 21-567, (Bristol-Myers Squibb Company), for the treatment of human immunodeficiency virus infection.

Notice of Meeting (PDF -48 KB) Final Agenda (PDF - 69 KB) (Word) Draft Agenda (PDF - 81 KB)(Word) Committee Roster (PDF - 91 KB) (Word) Additional Participants (PDF- 82 KB) (Word) Final Questions (PDF - 71 KB) (Word) Briefing Information Slides May 13, 2003 Transcript (PDF - 540 KB) (Word)

Date: May 14, 2003

Final Agenda (PDF - 70 KB) (Word) Draft Agenda (PDF - 75 KB) (Word) Committee Roster (PDF - 91 KB) (Word) Additional Participants (PDF - 92 KB) (Word) Final Questions (PDF - 59 KB) (Word) Briefing Information Slides Transcript (PDF - 426 KB) (Word)

Date March 3, 2003Committee: 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

Notice of Meeting (PDF -35 KB) Final Agenda (PDF - 86 KB) (Word) Draft Agenda (PDF - 98 KB) (Word) Final Questions (PDF - 72 KB) (Word) Draft Questions (PDF - 54 KB) (Word) Committee Roster (PDF - 81 KB) (Word) Consultants/Guests Roster (PDF - 64 KB) (Word) Briefing Information Slides Transcript (PDF - 577 KB) (Word)

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2002

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

2001

Date 10/24 - 25/01Committee: Biological Response Modifiers Advisory Committee Topic: Lentiviral vector gene transfer product for treatment of people with HIV

Draft Agenda Final Agenda Briefing information Questions to the Committee Roster Slides Transcript 10/24/01

Transcript 10/25/01

Date: 10/3/01Committee: Antiviral Drugs Advisory Committee Topic: Vireadâ„¢ (tenofovir disoproxil fumarate) Tablets, new drug application (NDA) 21-356 (Gilead Sciences) for the treatment of human immunodeficiency virus (HIV) infection,

Draft Agenda Final Agenda Roster - Committee Roster, consultants and guests Questions to the Committee (PDF - 91 KB)) Briefiing information Slides Transcript

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).

Agenda (PDF - 661 KB)) Roster - Committee Roster - guests and consultants Briefing information Slides Questions to the Committee Transcript (rich text format) Transcript (PDF, page 1 - 100) (639 KB) Transcript (PDF, page 101 - 200) (627 KB) Transcript (PDF, page 201- 221) (392 KB)

Date: 01/11/01Committee: Antiviral Drugs Advisory Committee Topic: Clinical trial design issues for patients with HIV-1 infection who have limited therapeutic options

Agenda (.doc) Agenda (PDF -17 KB) Briefing information Slides Transcript (rich text format) Transcript (page 1 - 100, PDF) (660 KB) Transcript (PDF, page 101 - 200) (657 KB) Transcript (PDF, page 201 - 300) (659 KB) Transcript (PDF, page 301 - 354) Roster (PDF - 92 KB)

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2000

Date: 10/16/00Committee: Antiviral Drugs Advisory Committee Topic: The use of surrogate markers in early development of immunomodulatory agents for the treatment of patients with HIV.

Agenda (PDF - 79 KB) Roster - Committee (PDF - 13 KB) Roster - guests and consultants (PDF - 122 KB) Briefing information Slides Transcript (rich text format) Transcript (PDF - 408)

Date: 9/14/00Committee: Blood Products Advisory CommitteeTopic: FDA blood or plasma donor deferral policy related to men who have had sex with men (MSMs) ~ Blood Donor Deferral for MSMs

Agenda (PDF -13 KB) Briefing information Transcript (PDF - 677 KB)

Date: 7/25/00Committee: 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.

Agenda (PDF - 98 KB) Roster - Committee (PDF - 13 KB) Roster - guests and consultants (PDF - 64 KB) Briefing information Slides Transcript (WORD) Transcript (PDF, page 1 - 100 ) (541 KB) Transcript (PDF, page 101 - 200) (548 KB) Transcript (PDF, page 201 - 300) (5 MB) Transcript (PDF, page 301 - 347) (251 KB)

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1999

Date: 11/2/99-11/3/99Committee: Antiviral Drugs Advisory CommitteeTopic: The role of genotypic and phenotypic HIV resistance testing in antiretroviral drug development

Background Transcript, November 2, 1999 (rich text format) Transcript, November 2, 1999 (PDF, page 1 - 100) (503 KB) Transcript, November 2, 1999 (PDF, page 101- 200) (533 KB) Transcript, November 2, 1999 (PDF, page 201 - 271) (4.49 MB) Transcript, November 3, 1999 (rich text format) Transcript, November 3, 1999 (PDF, page 1 - 97) (994 KB) Transcript, November 3, 1999 (PDF, page 98 - 197) (432 KB) Transcript, November 3, 1999 (PDF, page 198 - 229) (662 KB)

Date 11/1/99Committee: Antiviral Drugs Advisory CommitteeTopic: Adefovir, new drug application (NDA) 20- 993, adefovir dipivoxil (Gilead Sciences Inc.), for the treatment of human immunodeficiency virus infection.

Meeting announcement (txt) Meeting announcement (PDF - 1744 KB) Background Transcript (rich text format) Transcript (PDF, page 1 - 100) (620 KB) Transcript (PDF, page 101 - 200) (534 KB) Transcript (PDF, page 201- 260) (367 KB) Transcript (PDF, page 261 - 301) (6.3 MB)

Date: 10/4/99Committee: 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.

Agenda (PDF - 48 KB) Briefing Information (PDF - 458 KB) Roster (PDF - 11134 KB) Transcript (PDF, page 1 - 100) (3.9 MB) Transcript (PDF, page 101 - 195) (3.7 MB)

Date: 09/17/99Committee: Blood Products Advisory CommitteeTopic: 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.

Notice of Meeting (PDF - 20 KB) Briefing Information Background Information (PDF - 225 KB)

Transcript (rich text format) Transcript PDF, pages 1 - 100) (4 MB) Transcript (PDF, pages 101 - 195) (3.8 MB)

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1998

Date: 11/2/98Committee: Antiviral Drugs Advisory CommitteeTopic: Ziagen (abacavir sulfate), new drug application (NDA) 20-977/20-978 to treat HIV infection Transcript (Rich Text Format) Transcript (PDF - 166 KB)

Date: 7/14/98Committee: Antiviral Drugs Advisory CommitteeTopic: Presentations on general regulatory procedures and policies, including overview of the Food and Drug Administration Modernization Act of 1997Transcript (PDF- 4 MB)

Date: 5/6/98Committee: Antiviral Drugs Advisory CommitteeTopic: 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: 7/14/97-7/15/97Committee: Antiviral Drugs Advisory CommitteeTopic: Utility of plasma HIV RNA as an endpoint in clinical trials for drugs to treat HIV infection, and review of pediatric HIV dataTranscript (PDF Format - 12 MB)Additional Document: Summary Minutes

Date: 6/23/97Committee: Oncologic Drugs Advisory CommitteeTopic: 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: 11/22/96Committee: Antiviral Drugs Advisory CommitteeTopic: 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: 11/20-22/96Committee: 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 HealthTopic: 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: 6/7/96Committee: Antiviral Drugs Advisory CommitteeTopic: Viramune (nevirapine), new drug application (NDA) 20-636 for the treatment of HIV infectionTranscripts from 1996 meetings are available from the Freedom of Information Office.

Date: 3/15/96Committee: Antiviral Drugs Advisory Committee joint meeting with Ophthalmic Drugs SubcommitteeTopic: Vistide (cidofovir, intravenous), new drug application (NDA) 20-638 for the treatment of CMV retinitisSummary Minutes Transcripts from 1996 meetings are available from the Freedom of Information Office.

Date: 3/1/96Committee: Endocrinologic and Metabolic Drugs Advisory Committee joint meeting with Antiviral Drugs Advisory CommitteeTopic: Serostim (somatropin), new drug application (NDA) 20-604 for the treatment of AIDS wasting or cachexiaTranscripts from 1996 meetings are available from the Freedom of Information Office.

Date: 3/1/96Committee: Antiviral Drugs Advisory CommitteeTopic: Crixivan (indinavir capsules), new drug application (NDA) 20-685 for the treatement of HIV infectionTranscripts from 1996 meetings are available from the Freedom of Information Office.

Date: 2/29/96Committee: Antiviral Drugs Advisory CommitteeTopic: Norvir (ritonavir), new drug application (NDA) 20-659/20-68 for the treatement of HIV infectionTranscripts from 1996 meetings are available from the Freedom of Information Office.

Date: 2/28/96Committee: Antiviral Drugs Advisory CommitteeTopic: Retrovir (zidovudine), new drug application (NDA) 19-665/19-919Transcripts from 1996 meetings are available from the Freedom of Information Office.

Date: 2/28/96Committee: Antiviral Drugs Advisory CommitteeTopic: 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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