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A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00029913
Recruitment Status : Completed
First Posted : January 25, 2002
Last Update Posted : September 2, 2010
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
HIV Vaccine Trials Network

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.

Condition or disease Intervention/treatment
HIV Infections Other: Observation

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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.
Other: Observation
Observation of participants who received HIV preventive vaccine and became infected.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who were enrolled in HIV preventive vaccine clinical trials and became HIV infected as a result of the vaccine.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00029913

Show Show 21 study locations
Sponsors and Collaborators
HIV Vaccine Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Connie Celum, MD University of Washington
Study Chair: Scott Hammer, MD Columbia University
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Responsible Party: Erik Schwab, HVTN Identifier: NCT00029913    
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:
AIDS Vaccines
CD4 Lymphocyte Count
Disease Progression
Viral Load
HIV Preventive Vaccine
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
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