United States of America

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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 Microbicides PrEP PrEP & Microbicides Partner Treatment

Vaccines

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 a DNA HIV vaccine boosted with a modified vaccinia [HVTN 065]
Phase: I
Product Being Tested: Prime: A prime boost strategy with DNA plasmid with gag, pro, RT, env, tat, rev, vpu with boost MVA vector with gag, pol, env
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, the HIV Vaccine Trials Network, GeoVax, University of Alabama at Birmingham, University of Maryland - Institute of Human Virology, Harvard Medical School/ Brigham & Women's Hospital, St. Louis University - New Hope Building, University of Rochester, Vanderbilt University Hospital
Total participants: 120
Countries: US
Trial sites in US: Baltimore, MD; Birmingham, AL; Boston, MA; Nashville, TN; Rochester, NY; St Louis, MI
Results expected: n/a
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00301184?term=HVTN+065&rank=1


Trial: Evaluation of the safety and immune response of 2 experimental HIV vaccines [HVTN 067]
Phase: I
Product Being Tested: DNA Vaccine EP-1233 and recombinant MVA-HIV polytope vaccine MVA-mBN32, separately and in a combined prime-boost regimen
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, HIV Vaccine Trials Network, Pharmexa-Epimmune, Bavarian Nordic
Total participants: 108
Countries: US
Trial sites in US: Baltimore, MD; Nashville, TN; Rochester, NY
Results expected: n/a
For more information: http://www.hvtn.org/faq/067/HVTN067FAQ_eng_Final.pdf


Trial: Safety of and immune response to a DNA HIV vaccine followed by an adenoviral vaccine boost given three different ways to HIV uninfected adults [HVTN 069]
Phase: I
Product Being Tested: A prime boost strategy with DNA vaccine with gag, pol, nef + env and Adenovirus 5 vector with gag, pol + env (intramuscularly, intradermally, subcutaneously)
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, HIV Vaccine Trials Network, Vaccine Research Center, NY Blood Center, Association Civil Impacta Salud y Educacion (IMPACTA)
Total participants: 90
Countries: Peru, US
Trial sites in US: Birmingham, AL; Boston, MA; New York, NY; Providence, RI; Seattle, WA
Results expected: n/a
For more information: http://www.hvtn.org/faq/069/HVTN069FAQ_eng_Final.pdf


Trial: Evaluation of the safety and immunogenicity of PENNVAX-B with IL-12 or IL-15 DNA plasmid adjuvants [HVTN 070]
Phase: I
Product Being Tested: PENNVAX-B (gag, pol, env) alone, in combination with IL-12 DNA plasmid adjuvants, or with 2 different doses of IL-15
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, HIV Vaccine Trials Network, University of Pennsylvania/Wyeth, University of Alabama at Birmingham, San Francisco Department of Public Health, Mt. Zion Hospital, New York Blood Center
Total participants: 120
Countries: US
Trial sites in US: Birmingham, AL; Bronx, NY; New York, NY; San Francisco, CA
Results expected: n/a
For more information: http://www.iavireport.org/trials-db/Pages/ShowTrial.aspx?TrialID=1392


Trial: Evaluation of the safety and immune response of an experimental HIV vaccine [HVTN 071]
Phase: I
Product Being Tested: Adenovirus 5 vector with gag, pol, nef
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, HIV Vaccine Trials Network, Merck
Total participants: 35
Countries: US
Trial sites in US: Birmingham, AL; Nashville, TN; Rochester, NY; Seattle, WA
Results expected: n/a
For more information: http://www.hvtn.org/faq/071/HVTN071FAQ_v1_eng.pdf


Trial: Evaluation of the safety and immunogenicity of two experimental vaccine vectors in a prime-boost combination or used singularly as a booster in subjects primed with DNA vaccines [HVTN 072]
Phase: I
Product Being Tested: DNA and Adenovirus 5 or 35 vectors, all with env in varying prime-boost combinations
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, HIV Vaccine Trials Network, Vaccine Research Center
Total participants: 17
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: A Phase I evaluation of Local and Systemic Reactogenicity Following Serial Administration of ADVAX, a Clade C DNA Vaccine, ADVAX e/g + ADVAX p/n-t, by Ichor TriGrid™ in Vivo Electroporation [IAVI C004/DHO-614]
Phase: I
Product Being Tested: Serial administration of ADVAX, ADVAX e/g + ADVAX p/n-t, by Ichor TriGrid™ in vivo electroporation. The ADVAX vaccine contains two vectors: ADVAX e/g, with env and gag, and ADVAXp/n-t with pol and nef-tat
Sponsor, funder, developer, collaborator: Rockefeller University, Aaron Diamond AIDS Research Center Bill and Melinda Gates Foundation Ichor Medical Systems Incorporatedm, International AIDS Vaccine Initiative
Total participants: 40
Countries: US
Trial sites in US: New York, NY
Results expected: Preliminary data will be presented at AIDS Vaccine 2009 in Paris, Oct 2009; final data expected 2010
For more information: http://clinicaltrials.gov/ct/show/NCT00545987?order=2


Trial: Study of Vaccination Schedule of Experimental HIV Vaccines [VRC 011]
Phase: I
Product Being Tested: DNA vaccine with gag, pol, nef + env or Adenovirus vector with gag, pol + env
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases, Vaccine Research Center, National Institutes of Health Clinical Center
Total participants: 60
Countries: US
Trial sites in US: Bethesda, MD
Results expected: n/a
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00321061?term=VRC+011&rank=1


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: Pharmacokinetic study of the vaginal microbicide agent 1% tenofovir gel [A04-095]
Phase: I
Product Being Tested: Tenofovir gel
Sponsor, funder, developer, collaborator: CONRAD, International Partnership for Microbicides, United States Agency for International Development, University of Pittsburgh Medical Center, Advances in Health Inc.
Total participants: 49
Countries: Dominican Republic, United States
Trial sites in United States: Houston, TX; Pittsburg, PA
Results expected: n/a


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 and persistence of 0.1% UC-781 vaginal gel in HIV-1 seronegative women
Phase: I
Product Being Tested: UC-781 gel
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Disease, CONRAD, Magee-Womens Hospital of University of Pittsburgh Medical Center
Total participants: 60
Countries: US
Trial sites in US: Pittsburg, PA
Results expected: n/a
For more information: http://clinicaltrials.gov/ct2/show/NCT00441909


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: Responses to repeated vaginal applications of tenofovir gel [TFV 010]
Phase: I
Product Being Tested: Tenofovir gel
Sponsor, funder, developer, collaborator: National Institute of Allergy and Infectious Diseases
Total participants: 30
Countries: United States
Trial sites in US: n/a
Results expected: n/a


Trial: UC-781 gel pilot study
Phase: I
Product Being Tested: UC-781 gel
Sponsor, funder, developer, collaborator: CONRAD
Total participants: 15
Countries: United States
Trial sites in US: n/a
Results expected: n/a
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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: Q4 2010, 1st interim analysis in Q4/09


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
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Partner Treatment

Trial: Evaluation of the effectiveness of two antiretroviral treatment strategies to prevent HIV transmission in HIV-serodiscordant couples [HPTN 052]
Phase: III
Product Being Tested: Highly active antiretroviral therapy for HIV prevention
Sponsor, funder, developer, collaborator: HIV Prevention Trials Network
Total participants: 1,750 couples
Countries: Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, US, Zimbabwe
Trial sites in US: Boston, MA
Results expected: n/a
For more information: target="_blank">http://www.hptn.org/research_studies/hptn052.asp
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*WHO, UNAIDS, and UNICEF. Epidemiological Fact Sheet on HIV and AIDS: Core data on epidemiological and response United States of America 2008 Update. 2008.: http://apps.who.int/globalatlas/predefinedReports/EFS2008/full/EFS2008_US.pdf