A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
A Multi-Site Evaluation of Virologic, Immunologic, and Clinical Natural History of Participants Enrolled in Phase I and Phase II HIV-1 Vaccine Protocols or HIV-1 Vaccine Preparedness Cohorts Who Develop HIV-1 Infection Subsequent to Trial Enrollment
2 other identifiers
observational
54
4 countries
21
Brief Summary
Despite risk reduction counseling, some individuals in HIV vaccine trials or vaccine preparedness studies may engage in risk behavior that results in HIV infection. The purpose of the HVTN 403 study is to find out more about how persons respond to HIV infection if they have received an experimental HIV-1 vaccine before they became HIV infected. Some people in HVTN 403 received an experimental HIV vaccine as a participant in a clinical trial before getting infected with HIV. Other people in this study were in a vaccine preparedness study when they got infected with HIV. None of these individuals became infected with HIV as result of their participation in an HIV vaccine or vaccine preparedness study. HVTN 403 will compare immune responses between those who previously received an experimental HIV vaccine and those who did not. Information learned from this study may be important in guiding future developments of new HIV vaccines and other treatments for HIV and AIDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2002
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2002
CompletedFirst Posted
Study publicly available on registry
January 25, 2002
CompletedStudy Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedSeptember 2, 2010
August 1, 2010
7.3 years
January 24, 2002
August 31, 2010
Conditions
Keywords
Study Arms (1)
1
Observation of participants includes a physical exam and collection of fluids. Study visits occur at Days 0, 7, 14, 28 and at Months 2, 3, 6 and every 6 months thereafter.
Interventions
Observation of participants who received HIV preventive vaccine and became infected.
Eligibility Criteria
Participants who were enrolled in HIV preventive vaccine clinical trials and became HIV infected as a result of the vaccine.
You may qualify if:
- Participated in HVTN, AVEG, HIVNET Phase I or Phase II vaccine trials or HIV vaccine preparedness trial HVTN 903 and became HIV infected after study enrollment.
- Are able and willing to provide information so that they may be located.
You may not qualify if:
- Have a medical or mental problem that, in the opinion of the investigator, would interfere with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mt Zion Hospital
San Francisco, California, 94102, United States
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102, United States
University of MD - Inst. of Human Virology (IHV)
Baltimore, Maryland, 21201, United States
Jhu-Cir/Dc
Baltimore, Maryland, 21205, United States
Johns Hopkins Univ
Baltimore, Maryland, 21205, United States
Fenway Community Health
Boston, Massachusetts, 02115, United States
Harvard University / Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Saint Louis University School of Medicine
St Louis, Missouri, 63110, United States
New York Blood Ctr / Union Square
New York, New York, 10003, United States
Columbia Univ
New York, New York, 10032, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Miriam Hosp
Providence, Rhode Island, 02906, United States
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232, United States
Fred Hutchinson Cancer Research Ctr
Seattle, Washington, 98109, United States
Hospital Escola Sao Francisco de Assis (HESFA)
Cidade Nova, 20210-303, Brazil
Asociacion Civil Selva Amazonica
Iquitos, Loreto, Peru
Impacta - Asociacion Civil Impacta Salud y Educaci
Lima, Peru
KOSH District HVTU
Klerksdorp, North West, 2571 SF, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanat
Bertsham, 2013, South Africa
University of Cape Town. Institute of Infectious Diseases
Mowbray, 7705, South Africa
Related Publications (1)
Seage GR 3rd, Holte SE, Metzger D, Koblin BA, Gross M, Celum C, Marmor M, Woody G, Mayer KH, Stevens C, Judson FN, McKirnan D, Sheon A, Self S, Buchbinder SP. Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study. Am J Epidemiol. 2001 Apr 1;153(7):619-27. doi: 10.1093/aje/153.7.619.
PMID: 11282787BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Connie Celum, MD
University of Washington
- STUDY CHAIR
Scott Hammer, MD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
January 24, 2002
First Posted
January 25, 2002
Study Start
April 1, 2002
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
September 2, 2010
Record last verified: 2010-08