HIV/AIDS Statistics for the United States of America
Total population in thousands (2007): 305,826*
Number of people living with HIV (2007): 1,200,000*
Adults aged 15 to 49 prevalence rate (2007): 0.6*
Women aged 15 to 24 prevalence rate (2007): 0.3*
Men aged 15 to 24 prevalence rate (2007): 0.7*
Adults aged 15 and up living with HIV (2007): 1,100,000*
Women aged 15 and up living with HIV (2007): 230,000*
Deaths due to AIDS (2007): 22,000*
Ongoing biomedical HIV prevention research trials in United States of America
Vaccines
Trial: IAVI B003/IPCAVD-004
Phase: I
Start Date: October 2010
Sponsor, funder, developer: IAVI, HVTN, NIAID, Beth Israel Deaconess Medical Center, Ragon Institute of MGH, MIT, Harvard
Total participants: 212
Vaccine(s): Prime: Ad26.EnvA01 Boost: Ad35- ENV
Trial: RV262
Phase: I
Start Date: September 2010
Sponsor, funder, developer: NIAID
Total participants: 92
Vaccine(s): Prime: PENNVAX-G DNA (ENV & GAG) Administered by Intramuscular Biojector 2000 or CELLECTRA Intramuscular Electroporation Device Boost: MVA-CMDR (HIV-1 CM235 ENV/CM240 GAG/POL)
Clade: A, B, C, D, E
Trial: HVTN 076
Phase: I
Start Date: May 2011
Sponsor, funder, developer: DAIDS, HVTN, VRC
Total participants: 45
Vaccine(s): VRC-HIVDNA016-00-VP clade B gag, pol, and nef, clade A env, clade B env, clade C env VRC-HIVADV014-00-VP clade B gag-pol, clade A env, clade B env, clade C env
Clade: A, B, C
Trial: HVTN 082
Phase: I
Start Date: January 2010
Sponsor, funder, developer: NIAID, HVTN
Vaccine(s): VRC-HIVDNA016-00-VP; VRC-HIVADV014-00-VP
Trial: HVTN 083
Phase: I/II
Start Date: October 2010
Sponsor, funder, developer: DAIDS, HVTN, VRC
Total participants: 180
Vaccine(s): rAd35:(VRC-HIVADV027-00-VP); rAd5: (VRC-HIVADV038-00-VP); rAd5: (VRC-HIVADV052-00-VP)
Inserts: rAD35: env clade A; rAD5(038): env clade A; rAD5(052) env clade B
Clade: A, B
Trial: HVTN 204
Phase: II
Start Date: August 2006
Sponsor, funder, developer: NIAID, HVTN
Total participants: 480
Vaccine(s): DNA vaccine: VRC-HIVDNA016-00-VP, followed by adenoviral vector vaccine, VRC-HIVADV014-00-VP
Clade: A, B, C
Trial: Prime-boost vaccine regimen of pGA2/JS7 DNA and MVA/HIV62 [HVTN 205]
Phase: II
Product Being Tested: A prime boost strategy with DNA vaccine containing gag, pol, env, rat, rev, vpu Boost- MVA vaccine containing gag, pol, env
Sponsor, funder, developer, collaborator: GeoVax, HIV Vaccine Trials Network
Total participants: 225
Countries: Peru, US
Trial sites in US: Atlanta, GA; Birmingham, AL; Boston, MA; Nashville, TN; New York, NY; Rochester, NY; Seattle, WA; San Francisco, CA
Results expected: n/a
Trial: Safety of and immune response to an Adenoviral HIV-1 vaccine [Ad26.ENVA.01]
Phase: I
Product Being Tested: Recombinant adenovirus serotype 26 (rAd26) vaccine
Sponsor, funder, developer, collaborator: Integrated Preclinical/Clinical AIDS Vaccine Development, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Crucell
Total participants: 48
Countries: US
Trial sites in US: Boston, MA
Results expected: n/a
Trial: Safety and immune response to a recombinant adenovirus HIV-1 vaccine [Ad5HVR48.ENVA.01]
Phase: I
Product Being Tested: Recombinant Adenovirus HIV-1 Vaccine, Ad5HVR48.ENVA.01
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, Brigham and Women's Hospital
Total participants: 48
Countries: US
Trial sites in US: Boston, MA
Results expected: n/a
For more information: http://clinicaltrials.gov/show/NCT00695877?order=1
Trial: Evaluation of the safety and immunogenicity of Ad35-GRIN/ENV HIV vaccine [B001]
Phase: I
Product Being Tested: Adenovirus serotype 35 vector. Ad35-GRIN/ENV consists of two vectors: Ad35-GRIN vector with gag, reverse transcriptase, integrase, and nef Ad35-ENV vector with gp140 env
Sponsor, funder, developer, collaborator: International AIDS Vaccine Initiative, University of Rochester Medical Center
Total participants: 42
Countries: US
Trial sites in US: Rochester, NY
Results expected: 2010
Trial: DVP-1
Phase: I
Product Being Tested: Prime-boost regimen with PolyEnv, EnvPro, EnvDNA
Sponsor, funder, developer, collaborator: St. Jude's Children's Research Hospital
Total participants: 20
Countries: US
Trial sites in US: n/a
Results expected: n/a
Trial: Safety of and immune response to HIV vaccines SAAVI DNA-C2 and SAAVI MVA-C [HVTN 073]
Phase: I
Product Being Tested: A prime boost strategy with SAAVI DNA-C2 and SAAVI MVA-C; DNA plasmid vaccine with gag, RT, tat, nef, env
Sponsor, funder, developer, collaborator: HIV Vaccine Trials Network, South African AIDS Vaccine Initiative, Brigham and Women's Hospital CRS, Fenway Community Health Clinical Research Boston, Crossroads, Chris Hani Baragwanath Hospital
Total participants: 48
Countries: South Africa, US
Trial sites in US: Boston, MA
Results expected: n/a
Trial: Evaluation of the safety and immunogenicity of recombinant adenoviral subtype 35 and subtype 5 vaccines as a heterologous prime-boost or as boosts to recombinant DNA [HVTN 077]
Phase: IB
Product Being Tested: Recombinant Adenoviral Subtype 35 (rAd35) and Subtype 5 (rAd5) HIV-1 Vaccines When Given as a Heterologous Prime-Boost Regimen or as Boosts to a Recombinant DNA Vaccine in Healthy, Ad5-Naïve and Ad5-Exposed (VRC-HIVDNA044-00-VP;VRC-HIVADV027-00-VP;VRC-HIVADV038-00-VP)
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Disease, the HIV Vaccine Trials Network, Alabama Vaccine, San Francisco Vaccine and Prevention, Hope Clinic of the Emory Vaccine Center, NY Blood Center/Union Square, NY Blood Ctr./Bronx, University of Rochester HVTN
Total participants: 192
Countries: US
Trial sites in US: Birmingham, AL; Bronx, NY; Decatur, GA; New York, NY; Rochester, NY; San Francisco, CA
Results expected: n/a
For more information:
Trial: Safety and effectiveness of DNA vaccine and recombinant adenoviral vector vaccine in circumcised men [HVTN 505]
Phase: II
Product Being Tested: HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine (VRC-HIVDNA016-00-VP;VRC-HIVADV014-00-VP)
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Disease, the HIV Vaccine Trials Network, Alabama Vaccine, San Francisco Vaccine and Prevention San Francisco, Hope Clinic of the Emory Vaccine Center Decatur, VRC Clinical Trials Core, Fenway Community Health Clinical Research Site, University of Rochester HVTN, HIV Prevention & Treatment, Market Street Philadelphia, FHCRC/UW Vaccine Seattle
Total participants: 1,350
Countries: US
Trial sites in US: Bethesda, MD; Birmingham, AL; Boston, MA; Decatur, GA; Philadelphia, PA; Rochester, NY; San Francisco, CA; Seattle, WA
Results expected: n/a
For more information: http://clinicaltrials.gov/show/NCT00919789?order=22
Trial: Evaluation of the safety and immunogenicity of an HIV-1 Adenoviral Vector Serotype 35 [VRC 012]
Phase: I
Product Being Tested: HIV-1 adenovirus vector vaccine VRCHIVADV027-00VP with dose escalation and prime-boost with an HIV-1 adenovirus vector vaccine, VRC-HIVADV038-00-VP
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Disease, Vaccine Research Center
Total participants: 35
Countries: US
Trial sites in US: n/a
Results expected: n/a
Trial: Safety, tolerability and immunogenicity study of a Multiclade Recombinant HIV-1 Adenoviral Vector Vaccine administered by needle or biojector methods of intramuscular injection [VRC 015 (08-I-0171)]
Product Being Tested: Multiclade Recombinant HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Disease, Vaccine Research Center, National Institutes of Health Clinical Center
Total participants: 40
Countries: US
Trial sites in US: Bethesda, MD
Results expected: n/a
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Microbicides
Trial: Dapivirine gel expanded safety study [IPM 020]
Phase: I/II
Product being tested: Dapivirine gel
Sponsor, funder, developer, collaborator: International Partnership for Microbicides
Total participants: 180
Countries: US
Trial sites in US: Baltimore, MD; Birmingham, AL; Chicago, IL; Seattle, WA
Results expected: April 2010
For more information:
http://clinicaltrials.gov/ct2/show/NCT00799058?term=IPM+020&rank=1
Trial: Maternal pharmacokinetics and placental perfusion of tenofovir/PMPA gel [MTN-002]
Phase: I
Product being tested: Tenofovir gel
Sponsor, funder, developer, collaborator: Microbicide Trials Network, Division of AIDS/National Institute of Allergey and Infectious Diseases; Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institue of Mental Health; CONRAD; Magee-Womens Hospital of UPMC; Pittsburgh CRS
Total participants: 16
Countries: US
Trial sites in US: Pittsburg, PA
Results expected: 2010-2011
For more information:
http://clinicaltrials.gov/ct2/show/NCT00540605?term=MTN-002&rank=1
Trial: Safety and acceptability of 3% w/w SPL7013 Gel (VivaGel®) applied vaginally in sexually active young women [MTN-004]
Phase: I
Product being tested: VivaGel® gel [SPL7013]
Sponsor, funder, developer, collaborator: Microbicide Trials Network, Division of AIDS/National Institute of Allergey and Infectious Diseases; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Starpharma
Total participants: 61
Countries: Puerto Rico, United States
Trial sites in US: Tampa, FL
Results expected: 2010
For more information: http://www.mtnstopshiv.org/news/studies/mtn004/backgrounder
Trial: Safety of Acidform lubricant (Amphora) in women at low risk for HIV-1 infection [AF 020]
Phase: I
Product being tested: Acidform gel
Sponsor, funder, developer, collaborator: Albert Einstein College of Medicine, National Institute of Allergy and Infectious Diseases/Division of Acquired Immunodeficiency Syndrome
Total participants: 36
Countries: US
Trial sites in US: Bronx, NY
Results expected: n/a
Trial: Project Gel
Phase: I
Product being tested: Tenofovir and placebo gel
Sponsor, funder, developer, collaborator: NICHD, NIMH, Conrad
Total participants: 240 MSM
Countries: US, Puerto Rico
Results expected: Ongoing/Dec 2012
Trial: MTN 007
Phase: I
Product being tested: Tenofovir gel
Sponsor, funder, developer, collaborator: NIAID, NIMH, NIH, CONRAD
Total participants: 63 women and men
Countries: US
Results expected: Ongoing/Q1 2011
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Pre-Exposure Prophylaxis
Trial: Pre-Exposure Prophylaxis Initiative [iPrEx]
Phase: III
Product Being Tested: Daily oral TDF/FTC (Truvada®)
Sponsor, funder, developer, collaborator: National Institute of Health, Bill and Melinda Gates Foundation, Fenway Community Health, San Francisco Department of Public Health
Total participants: 2,499
Countries: Brazil, Ecuador, Peru, South Africa, Thailand, US
Trial sites in US: Boston, MA
Results expected: Announced in Q4 2010. For more information visit the
Global iPrEx page or
AVAC's iPrEx page
Trial: Adherence and pharmacokinetics study of oral and vaginal preparations of tenofovir [MTN-001]
Phase: IIb
Product Being Tested: Tenofovir gel, oral TDF
Sponsor, funder, developer, collaborator: Microbicide Trials Network, Division of AIDS/National Institute of Allergey and Infectious Diseases; Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institue of Mental Health ; Gilead, CONRAD
Total participants: 144
Countries: South Africa, Uganda, US
Trial sites in US: Bronx, NY; Birmingham, AL; Cleveland, OH; Pittsburgh, PA
Results expected: 2010
For more information: http://clinicaltrials.gov/ct2/show/NCT00592124?term=MTN-001&rank=1
http://www.mtnstopshiv.org/news/studies/mtn001
Trial: Adolescent Trials Network (ATN)
PCS 082: Acceptability and Feasibility of a PrEP Trial with YMSM
Phase: II
Product Being Tested: daily coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Sponsor, funder, developer, collaborator: National Institute of Health, National Institute of Child Health and Human Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Jr. Hospital of Cook County
Total participants: 99
Countries: US
Trial sites in US: Chicago, IL
Results expected: March 2011
http://www.clinicaltrials.gov/ct2/show/NCT01033942?term=082&rank=8
Trial: US Extended Safety Trial [CDC 4323]
Phase: II
Product Being Tested: Daily oral TDF
Sponsor, funder, developer, collaborator: Center for Disease Control
Total participants: 400
Countries: US
Trial sites in US: Atlanta, GA; Boston, MA; San Francisco, CA
Results expected: Q3 2010
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PrEP & Microbicides
Trial: Adherence and pharmacokinetics study of oral and vaginal preparations of tenofovir [MTN-001]
Phase: II
Product Being Tested: Tenofovir gel, oral TDF
Sponsor, funder, developer, collaborator: Microbicide Trials Network, Division of AIDS/National Institute of Allergey and Infectious Diseases; Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institue of Mental Health, Gilead, CONRAD
Total participants: 144
Countries: South Africa, Uganda, United States
Trial sites in US: Bronx, NY; Birmingham, AL; Cleveland, OH; Pittsburgh, PA
Results expected: 2010
For more information: , http://clinicaltrials.gov/ct2/show/NCT00592124?term=MTN-001&rank=1
http://www.mtnstopshiv.org/news/studies/mtn001
Trial: Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet (RMP 002/MTN 006)
Phase: I
Product Being Tested: Vaginally-formulated tenofovir 1% topical gel when applied rectally; oral TDF
Sponsor, funder, developer, collaborator: CONRAD, Gilead, Microbicide Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)
Total participants: 18
Countries: US
Trial sites in US: Los Angeles, CA; Pittsburgh, PA
Results expected: n/a
For more information: http://www.mtnstopshiv.org/node/9 ,
http://clinicaltrials.gov/ct2/show/NCT00984971