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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


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Not Enrolling
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HIV Infections

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Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Connie Celum, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington

Authority:

United States: Federal Government

Study ID:

HVTN 403

NCT ID:

NCT00029913

Start Date:

April 2002

Completion Date:

July 2009

Related Keywords:

  • HIV Infections
  • Placebos
  • AIDS Vaccines
  • CD4 Lymphocyte Count
  • Disease Progression
  • Viral Load
  • HIV Preventive Vaccine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Univ of Alabama at BirminghamBirmingham, Alabama  35294
San Francisco Dept of Hlth / AIDS OfficeSan Francisco, California  94102
Fred Hutchinson Cancer Research CtrSeattle, Washington  98109
Columbia UnivNew York, New York  10032
Univ of Rochester Med CtrRochester, New York  14642
Mt Zion HospitalSan Francisco, California  94102
Johns Hopkins UnivBaltimore, Maryland  21205
Jhu-Cir/DcBaltimore, Maryland  21205
University of MD - Inst. of Human Virology (IHV)Baltimore, Maryland  21201
Harvard University / Brigham and Women's HospitalBoston, Massachusetts  02115
Fenway Community HealthBoston, Massachusetts  02115
Saint Louis University School of MedicineSaint Louis, Missouri  63110
New York Blood Ctr / Union SquareNew York, New York  10003
Miriam HospProvidence, Rhode Island  02906
Vanderbilt Univ HospNashville, Tennessee  37232