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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
HIV Vaccine Trials Network
ClinicalTrials.gov Identifier:
NCT00029913
First received: January 24, 2002
Last updated: August 31, 2010
Last verified: August 2010
  Purpose

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 Intervention
HIV Infections
Other: Observation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by HIV Vaccine Trials Network:

Estimated Enrollment: 54
Study Start Date: April 2002
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Observation
Observation of participants who received HIV preventive vaccine and became infected.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029913

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States, 94102
Mt Zion Hospital
San Francisco, California, United States, 94102
United States, Maryland
Johns Hopkins Univ
Baltimore, Maryland, United States, 21205
Jhu-Cir/Dc
Baltimore, Maryland, United States, 21205
University of MD - Inst. of Human Virology (IHV)
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Harvard University / Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Fenway Community Health
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia Univ
New York, New York, United States, 10032
New York Blood Ctr / Union Square
New York, New York, United States, 10003
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
Sponsors and Collaborators
HIV Vaccine Trials Network
Investigators
Study Chair: Connie Celum, MD University of Washington
Study Chair: Scott Hammer, MD Columbia University
  More Information

Additional Information:
Publications:
Responsible Party: Erik Schwab, HVTN
ClinicalTrials.gov Identifier: NCT00029913     History of Changes
Other Study ID Numbers: HVTN 403, 5U01AI068614
Study First Received: January 24, 2002
Last Updated: August 31, 2010
Health Authority: United States: Federal Government

Keywords provided by HIV Vaccine Trials Network:
Placebos
AIDS Vaccines
CD4 Lymphocyte Count
Disease Progression
Viral Load
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on August 20, 2014