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.
Search by Medication/Topic or by year
- Adefovir (adefovir dipivoxil) 11/1/99
- Aptivus (tipranavir/ritonavir) May 19, 2005
- Blood Donor Deferral for MSMs 9/14/2000
- Clinical trial design issues in the development of products
for the treatment of chronic hepatitis C infection 10/19-20/2006
- Clinical trial design-limited therapeutic options 01/11/2001
- Crixivan (indinavir) 3/1/1996
- Endpoints & plasma HIV RNA 7/14-15/1997
- Genotypic & phenotypic HIV resistance testing 11/2-/3/1999
- HIV drug sensitivity assays 09/17/1999
- Hivid (zalcitabine) 2/28/1996
- Immunomodulatory agents & surrogate markers 10/16/2000
- Isentress (raltegravir potassium), integrase inhibitor 9/5/2007
- Lentiviral vector gene therapy 10/24 - 25/2001
- Neonates with HIV 3/3/2003
- Norvir (ritonavir) 2/29/1996
- NTZ (nitazoxanide) 5/6/1998
- Perinatal HIV transmission 10/4/1999
- Pharmacokinetic data and its role in evaluation of
new formulations & dosing regimens 7/25/2000
- Radiesse - (flexible, semi-solid cohesive granular
implant) for HIV Lipoatrophy 8/24/2006
- Rapid HIV Test - Over-the-counter (OTC) for Home Use -
Proposed Studies to Support Approval 3/10/2006
- Rapid HIV testing - Over-the-counter (OTC) sale and home
use - conditions necessary to support approval of a home-use HIV test
kit 11/3/2005
- Rapid HIV Tests: Clinical Trial Design and Performance
Standards for Approval 6/14-15/2001
- Rapid HIV Tests: Applicability of WaiversCLIA Criteria
for In Vitro Diagnostic Tests 6/14-15/2001
- Re-entry for Donors Deferred Because of HIV or HCV NAT
or Serological Test Results 6/14-15/2001
- Regulatory procedures & FDAMA overview 7/14/1998
- Rescriptor (delavirdine) 11/22/1996
- Retrovir (zidovudine) 2/28/1996
- Reyataz (atazanavir) 5/13-14/2003
- Sculptra (poly L-lactic acid) facial filler implant
3/25/2004
- Selzentry - (maraviroc) 4/24/2007
- Serostim (somatropin) 3/1/1996
- Topical microbicides & clinical trial design 8/20/2003
- Vaginal topical microbicides - development of vaginal
products for preventing the transmission of HIV 11/20-22/1996
- Vaccine phase III trial review 9/23/2004
- Valcyte (valganciclovir) 2/27/2001
- Videx (didanosine) 2/28/1996
- Viramune (nevirapine) 6/7/1996
- Viread (tenofovir) 10/24-25/2001
- Vistide (cidofovir) 3/15/1996
- Ziagen (abacavir) 11/2/1998
- Zyrkamine (mitoguazone) for treatment of AIDS-related
non-Hodgkins lymphoma 6/23/1997
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2007
Topic:
Isentress (raltegravir potassium), integrase inhibitor 400 milligram tablets
(NDA) 22-145
,
Merck & Co.,
Inc., for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in
combination with other antiretroviral agents in treatment-experienced patients
with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Date:9/5/2007
Committee: Antiviral Drugs Advisory Committee
- Notice of Meeting
(View document in PDF format) (52
KB))
- Final Agenda (PDF)
(15.8KB)
- Draft Agenda (PDF)
(91 KB)
- Meeting Roster (Final) (PDF)
(51.4 KB)
- Meeting Roster (Draft) (PDF)
(80.6 KB)
- Committee Roster (PDF)
(87.1 KB)
- Final Questions (PDF)
(12.8 KB)
- Draft Questions (PDF)
(11.5 KB)
- Briefing
Information
- Slides
- Transcript: (Part1.pdf)
(289 KB), (Part2.pdf)
(249 KB), (Part3.pdf)
(181 KB)
Topic: Selzentry (maraviroc),
300 milligram tablets (NDA) 022-128 (Pfizer, Inc.), proposed for the treatment
of antiretroviral-experienced patients with chemokine (c-c motif) receptor
5 (CCR5)--tropic human immunodeficiency virus (HIV)
Date: 4/24/2007
Committee: Antiviral Drugs Advisory Committee
- Notice of Meeting (View document
in PDF format [51
KB])
- Nature and Basis Statements of Conflict(s) of Interest for April 24, 2007
(htm)
- Change in Meeting Location for April 24, 2007 Meeting (PDF
format) (15KB)
- Draft Agenda (PDF format)
(99 KB)
- Rosters : Committee (PDF
format) (78 KB),
Meeting (PDF
format) (80 KB)
- Briefing
Information
- Final
Questions for April 24, 2007 Meeting (PDF
format )
(12 KB)
- Final Report - Collaborative Approaches to HIV Drug Development: Planning
for Long-Term Monitoring of Seafetly in CCR5 Antagonist Development (Report
of an FDA/Forum on Collaborative HIV Research Joint Public Meeting) (PDFformat) (431
KB)
- Slides
- Summary Minutes (PDFformat) (39)
KB)
2006
Topic: Clinical trial design issues in the development of products for the
treatment of chronic hepatitis C infection
Date: 10/19-20/2006
Committee: Antiviral Drugs Advisory Committee
Topic: Radiesse, a sterile, non-pyrogenic, flexible,
semi-solid cohesive granular implant containing calcium hydroxylapatite granules
in a gel of glycerine, water and sodium carboxymethylcellulose, manufactured
by BioForm Medical, Inc.
Date: 8/24/2006
Committee: General and Plastic Surgery
Devices Panel
Topic: Proposed Studies to Support the Approval of Over-the-Counter
(OTC) Home-Use HIV Test Kits
Date: 3/10/2006
Comittee: Blood Products Advisory Committee
Return to Index
2005
Topic: An approach for home-use rapid HIV test kits
(for over-the-counter (OTC) availability of the OraQuick ADVANCE Rapid HIV-1/2
Antibody Test for use with oral fluid specimens), and a committee update on:
draft guidance on nucleic acid testing (NAT) for human immunodeficiency virus
(HIV)-1 and hepatitis C virus (HCV): Testing, product disposition, and donor
deferral and re-entry
Date: 11/3/2005
Committee: Blood Products Advisory Committee
- Notice of Meeting [View
document in PDF format (50KB)]
- Briefing Information
- Draft Agenda [View document in PDF
format (27
KB)]
- Committee Roster
- Slides
- Approaches
to Validation of Over-the-Counter (OTC) Home-Use HIV Test Kits, Elliot
Cowan, Ph.D., FDA
- An Approach for
a Rapid HIV Antibody Home-Use Oral Fluid Test, OraSure Technologies (PDF 1
MB)
- Changes
in HIV Testing Practices and Counseling Recommendations, Bernard
Branson, M.D., CDC [View the PowerPoint
slides]
- Quality
System Considerations for Over-the-Counter HIV Testing, Devery
Howerton, Ph.D., CDC [View the PowerPoint
slides]
- Psychological/Social
Issues Associated with HIV Testing and OTC Home-Use HIV Tests,
Joseph Inungu, M.D., Dr.PH, Central Michigan University [View the PowerPoint
slides]
- Office
of in Vitro Diagnostic Device Evaluation and Safety, Arleen
Pinkos, FDA [View the PowerPoint
slides]
- Open Public Hearing
- Written Statements
- Quick
Minutes
- Transcript
Return to Index
Topic: Aptivus (Tipranavir) 250 milligrams (mg) capsules,
new drug application (NDA) 021-814 (Boehringer Ingelheim Pharmaceuticals, Inc.),
indicated for the treatment of patients with HIV.
Date: 5/19/2005
Committee: Antiviral Drugs Advisory Committee
Return to Index
2004
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: 9/23/2004
Committee: Vaccines and Related Biological Products Advisory Committee
- Notice of Meeting [View
document in PDF format (48 KB)]
- Final Agenda [View
document
in PDF (7 KB)] [View
document in Word]
- Revised
Agenda [View
document in PDF (7.1 KB)] [View
document in Word]
- Draft Agenda [View
document
in PDF (7.9 KB)] [View
document in Word]
- Roster [View
document in PDF (5.5 KB)] [View
document in Word]
- Final Questions (PDF (6.2 KB) [View
document
in Word]
- Briefing Information
- Slides
- Transcript [View
document
in Word)
- Summary Minutes [View
document
in PDF (14 KB)] [View
document in Word]
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: 3/25/2004
Committee: General and Plastic Surgery Devices Panel (Center
for Devices and Radiological Health)
Return to Index
2003
Topic: Clinical trial design issues
in the development of topical microbicides for the reduction of HIV transmission.
Date: 8/20/2003
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: 5/13-14/2003
Committee: Antiviral Drugs Advisory Committee
Date: 5/14/2003
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
Date 3/3/2003
Committee: Anti-Infective Drugs Advisory Committee, Pediatric
Subcommittee
Return
to Index
2002
There were no FDA advisory committee meetings directly related to HIV/AIDS
during 2002
2001
Topic: Lentiviral vector gene transfer
product for treatment of people with HIV
Date 10/24-25/2001
Committee: Biological Response Modifiers 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: 10/3/2001
Committee: Antiviral Drugs Advisory Committee
Topics: Rapid HIV Tests and Serological
Test Results
- Clinical Trial Design and Performance Standards for Approval of Rapid HIV
Tests
- Re-entry for Donors Deferred Because of HIV or HCV NAT or Serological Test
Results
- CLIA Criteria for In Vitro Diagnostic Tests: Applicability of Waivers to
HIV Rapid Tests
Date: 6/14-15/2001
Committee: Blood Products 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: 2/27/2001
Committee: Antiviral Drugs Advisory Committee
Topic: Clinical trial design issues for patients with
HIV-1 infection who have limited therapeutic options
Date: 01/11/2001
Committee: Antiviral Drugs Advisory Committee
Return to Index
2000
Topic: The use of surrogate markers
in early development of immunomodulatory agents for the treatment of patients
with HIV.
Date: 10/16/2000
Committee: Antiviral Drugs 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: 9/14/2000
Committee: Blood Products 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: 7/25/2000
Committee: Antiviral Drugs Advisory Committee
- 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)
Return to Index
1999
Topic: The role of genotypic and phenotypic HIV resistance
testing in antiretroviral drug development
Date: 11/2-3/1999
Committee: Antiviral Drugs Advisory Committee
- 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)
Topic: Adefovir, new drug application (NDA) 20- 993,
adefovir dipivoxil (Gilead Sciences Inc.), for the treatment of human immunodeficiency
virus infection.
Date 11/1/1999
Committee: Antiviral Drugs Advisory Committee
- 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)
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: 10/4/1999
Committee: Antiviral Drugs Advisory Committee
- 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)
Topic: Reclassification of Human
Immunodeficiency Virus (HIV) drug sensitivity assays.
Date: 09/17/1999
Committee: Blood Products Advisory Committee
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)
Return to Index
1998
Topic: Ziagen (abacavir sulfate), new drug application (NDA) 20-977/20-978
to treat HIV infection
Date: 11/2/1998
Committee: Antiviral Drugs Advisory Committee
Transcript (Rich Text
Format)
Transcript (PDF -
166 KB)
Topic: Presentations on general regulatory procedures
and policies, including overview of the Food and Drug Administration Modernization
Act of 1997
Date: 7/14/1998
Committee: Antiviral Drugs Advisory Committee
Transcript (PDF- 4
MB)
Topic: NTZ (nitazoxanide), new drug application (NDA) 20-871
for treatment of Cryptosporidiosis
Date: 5/6/1998
Committee: Antiviral Drugs Advisory Committee
Transcript (Rich Text
Format)
Transcript (PDF -
12 MB)
Return to Index
1997
Topic: Utility of plasma HIV RNA as an endpoint
in clinical trials for drugs to treat HIV infection, and review of pediatric
HIV data
Date: 7/14-15/1997
Committee: Antiviral Drugs Advisory Committee
Transcript (PDF
Format - 12 MB)
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.
Date: 6/23/1997
Committee: Oncologic Drugs Advisory Committee
Transcript (Rich Text
Format)
Transcript (PDF)
Additional Documents: Slides (PDF)
Return to Index
1996
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Topic: Rescriptor (delavirdine), new drug application
(NDA) 20-705 for the treatment of HIV infection
Date: 11/22/1996
Committee: Antiviral Drugs Advisory Committee
Transcripts
from 1996 meetings are available from the Freedom
of Information Office.
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.
Date: 11/20-22/1996
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
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Topic: Viramune (nevirapine), new drug application (NDA)
20-636 for the treatment of HIV infection
Date: 6/7/1996
Committee: Antiviral Drugs Advisory Committee
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Topic: Vistide (cidofovir, intravenous), new drug application
(NDA) 20-638 for the treatment of CMV retinitis
Date: 3/15/1996
Committee: Antiviral Drugs Advisory Committee joint meeting
with Ophthalmic Drugs Subcommittee
Summary Minutes
Transcripts from 1996 meetings are available from the Freedom
of Information Office.
Topic: Serostim (somatropin), new drug application (NDA)
20-604 for the treatment of AIDS wasting or cachexia
Date: 3/1/1996
Committee: Endocrinologic and Metabolic Drugs Advisory Committee
joint meeting with Antiviral Drugs Advisory Committee
Transcripts
from 1996 meetings are available from the Freedom
of Information Office.
Topic: Crixivan (indinavir capsules), new drug application
(NDA) 20-685 for the treatement of HIV infection
Date: 3/1/1996
Committee: Antiviral Drugs Advisory Committee
Transcripts
from 1996 meetings are available from the Freedom
of Information Office.
Topic: Norvir (ritonavir), new drug application (NDA) 20-659/20-68
for the treatement of HIV infection
Date: 2/29/1996
Committee: Antiviral Drugs Advisory Committee
Transcripts
from 1996 meetings are available from the Freedom
of Information Office.
Topic: Retrovir (zidovudine), new drug application (NDA)
19-665/19-919
Date: 2/28/1996
Committee: Antiviral Drugs Advisory Committee
Transcripts from 1996 meetings are
available from the Freedom
of Information Office.
Topic: Discussion of recent studies with nucleoside analogues
for the treatment of HIV infection.
Date: 2/28/1996
Committee: Antiviral Drugs Advisory Committee
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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