The purpose of this study is to find out more about how persons respond to HIV-1 infection if they have received an experimental HIV-1 vaccine before they became HIV-infected. It is important to study people who have been given experimental HIV vaccines and who later became HIV-infected for several reasons. First, if HIV infection is found and then cleared, it is important to note the relationship between the virus and the vaccine. This may give an understanding of the immunity. A second reason is to better understand the immune response in those who received a vaccine compared to those who received placebo (no vaccine). If the vaccine does not prevent HIV infection, it will be important to study the progression of the disease. Understanding the immune response in vaccinated patients after infection and the impact on symptoms and disease progression may give valuable information for future vaccine trials and the effectiveness of HIV vaccines.
 

Condition
HIV Infections

Further Study Details: 

Expected Total Enrollment:  54

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.

 

Genders Eligible for Study:  Both

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.

 

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      San Francisco Dept of Hlth / AIDS Office, San Francisco,  California,  94102,  United States; Recruiting
      Mt Zion Hospital, San Francisco,  California,  94102,  United States; Recruiting
Maryland
      Johns Hopkins Univ, Baltimore,  Maryland,  21205,  United States; Recruiting
      JHU-CIR/DC, Baltimore,  Maryland,  21205,  United States; Recruiting
Massachusetts
      Harvard University / Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
      Fenway Community Health, Boston,  Massachusetts,  02115,  United States; Recruiting
Missouri
      Saint Louis University School of Medicine, Saint Louis,  Missouri,  63110,  United States; Recruiting
New York
      Columbia Univ, New York,  New York,  10032,  United States; Recruiting
      Univ of Rochester Med Ctr, Rochester,  New York,  14642,  United States; Recruiting
      New York Blood Ctr / Union Square, New York,  New York,  10003,  United States; Recruiting
Rhode Island
      Miriam Hosp, Providence,  Rhode Island,  02906,  United States; Recruiting
Tennessee
      Vanderbilt Univ Hosp, Nashville,  Tennessee,  37232,  United States; Recruiting
Washington
      Fred Hutchinson Cancer Research Ctr, Seattle,  Washington,  98109,  United States; Recruiting

Study chairs or principal investigators

Connie Celum, MD,  Study Chair,  University of Washington   
Scott Hammer, MD,  Study Chair,  Columbia University   

Study ID Numbers:  HVTN 403
Record last reviewed:  September 2004
Last Updated:  February 7, 2005
Record first received:  January 24, 2002
ClinicalTrials.gov Identifier:  NCT00029913
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-01