A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
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ClinicalTrials.gov Identifier: NCT00029913 |
Recruitment Status
:
Completed
First Posted
: January 25, 2002
Last Update Posted
: September 2, 2010
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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.
Condition or disease | Intervention/treatment |
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HIV Infections | Other: Observation |
It is important to study persons vaccinated with candidate HIV-1 vaccines who have become HIV-1 infected for the following reasons. First, if transient HIV-1 infection is detected and then is effectively suppressed or cleared, it will be important to document the antigenic relationship between the breakthrough virus and the vaccine epitopes to attempt to answer questions about the specificity and breadth of the immune response and the determinants of immunity. A second reason is to gain a better understanding of vaccine-induced responses in those participants who are transiently or persistently HIV-1-infected compared to placebo recipients who become HIV-1-infected. If the vaccine does not prevent HIV-1 infection, it will be important to characterize the course of the disease as measured by longitudinal viral load measurements, CD4+ counts, and clinical symptoms. Understanding the breadth, magnitude, and specificity of the immune response in partially or fully immunized vaccinees after infection and the impact on clinical symptoms and disease progression can potentially result in valuable information for the subsequent design of vaccine efficacy trials and, ultimately, in consideration of potential effectiveness of HIV-1 vaccines.
Study visits occur at Days 0, 7, 14, 28, then at 2 months, 3 months, 6 months, and every 6 months thereafter. At these visits, patients are given a physical exam, blood is drawn, and a donation of genital fluids is requested at certain visits. Patients are asked to donate samples of either semen (men) or cervical secretions (women); viral load is measured and compared to the amount and types of virus in the blood. He/she may refuse to donate these genital fluids and still be eligible to remain in the study. Primary medical care or medications for HIV infection are not provided by this study.
Study Type : | Observational |
Estimated Enrollment : | 54 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Study Start Date : | April 2002 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Group/Cohort | Intervention/treatment |
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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.
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Other: Observation
Observation of participants who received HIV preventive vaccine and became infected.
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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria
- 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.
Exclusion Criteria
- Have a medical or mental problem that, in the opinion of the investigator, would interfere with the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029913
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Mt Zion Hospital | |
San Francisco, California, United States, 94102 | |
San Francisco Dept of Hlth / AIDS Office | |
San Francisco, California, United States, 94102 | |
United States, Maryland | |
University of MD - Inst. of Human Virology (IHV) | |
Baltimore, Maryland, United States, 21201 | |
Jhu-Cir/Dc | |
Baltimore, Maryland, United States, 21205 | |
Johns Hopkins Univ | |
Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
Fenway Community Health | |
Boston, Massachusetts, United States, 02115 | |
Harvard University / Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Saint Louis University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
New York Blood Ctr / Union Square | |
New York, New York, United States, 10003 | |
Columbia Univ | |
New York, New York, United States, 10032 | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Rhode Island | |
Miriam Hosp | |
Providence, Rhode Island, United States, 02906 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Fred Hutchinson Cancer Research Ctr | |
Seattle, Washington, United States, 98109 | |
Brazil | |
Hospital Escola Sao Francisco de Assis (HESFA) | |
Cidade Nova, Brazil, 20210-303 | |
Peru | |
Asociacion Civil Selva Amazonica | |
Iquitos, Loreto, Peru | |
Impacta - Asociacion Civil Impacta Salud y Educaci | |
Lima 18, Peru | |
South Africa | |
KOSH District HVTU | |
Klerksdorp, North West Province, South Africa, 2571 SF | |
Perinatal HIV Research Unit, Chris Hani Baragwanat | |
Bertsham, South Africa, 2013 | |
University of Cape Town. Institute of Infectious Diseases | |
Mowbray, South Africa, 7705 |
Study Chair: | Connie Celum, MD | University of Washington | |
Study Chair: | Scott Hammer, MD | Columbia University |
Publications:
Responsible Party: | Erik Schwab, HVTN |
ClinicalTrials.gov Identifier: | NCT00029913 History of Changes |
Other Study ID Numbers: |
HVTN 403 5U01AI068614 ( U.S. NIH Grant/Contract ) |
First Posted: | January 25, 2002 Key Record Dates |
Last Update Posted: | September 2, 2010 |
Last Verified: | August 2010 |
Keywords provided by HIV Vaccine Trials Network:
Placebos AIDS Vaccines CD4 Lymphocyte Count |
Disease Progression Viral Load HIV Preventive Vaccine |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |