A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials
- Conditions
- HIV Infections
- Interventions
- Other: Observation
- Registration Number
- NCT00029913
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Observation 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.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
University of MD - Inst. of Human Virology (IHV)
🇺🇸Baltimore, Maryland, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
San Francisco Dept of Hlth / AIDS Office
🇺🇸San Francisco, California, United States
Mt Zion Hospital
🇺🇸San Francisco, California, United States
Jhu-Cir/Dc
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Univ
🇺🇸Baltimore, Maryland, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
New York Blood Ctr / Union Square
🇺🇸New York, New York, United States
Columbia Univ
🇺🇸New York, New York, United States
Hospital Escola Sao Francisco de Assis (HESFA)
🇧🇷Cidade Nova, Brazil
Miriam Hosp
🇺🇸Providence, Rhode Island, United States
Fred Hutchinson Cancer Research Ctr
🇺🇸Seattle, Washington, United States
Impacta - Asociacion Civil Impacta Salud y Educaci
🇵🇪Lima 18, Peru
Vanderbilt Univ Hosp
🇺🇸Nashville, Tennessee, United States
KOSH District HVTU
🇿🇦Klerksdorp, North West Province, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanat
🇿🇦Bertsham, South Africa
University of Cape Town. Institute of Infectious Diseases
🇿🇦Mowbray, South Africa
Harvard University / Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Fenway Community Health
🇺🇸Boston, Massachusetts, United States
Saint Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Asociacion Civil Selva Amazonica
🇵🇪Iquitos, Loreto, Peru