Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00029913 |
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: | Cohort, 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 |
Estimated Enrollment: | 54 |
Study Start Date: | April 2002 |
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.
|
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 |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants who were enrolled in HIV preventive vaccine clinical trials and became HIV infected as a result of the vaccine.
Inclusion Criteria
Exclusion Criteria
United States, Alabama | |
Univ of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Susan Duncan 205-975-2840 sduncan@byrd1917.his.uab.edu | |
United States, California | |
San Francisco Dept of Hlth / AIDS Office | Recruiting |
San Francisco, California, United States, 94102 | |
Contact: Rose Quinones 415-544-9014 rose_quinones@dph.sf.ca.us | |
Mt Zion Hospital | Recruiting |
San Francisco, California, United States, 94102 | |
Contact: Rose Quinones 415-544-9014 rose_quinones@dph.sf.ca.us | |
United States, Maryland | |
Johns Hopkins Univ | Active, not recruiting |
Baltimore, Maryland, United States, 21205 | |
JHU-CIR/DC | Active, not recruiting |
Baltimore, Maryland, United States, 21205 | |
University of MD - Inst. of Human Virology (IHV) | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Cynthia Starr Hendel, MSN, CRNP, CCRC (410) 706-1289 hendel@umbi.umd.edu | |
United States, Massachusetts | |
Harvard University / Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Kristen Whiteside 617-525-6778 kwhiteside@partners.org | |
Fenway Community Health | Active, not recruiting |
Boston, Massachusetts, United States, 02115 | |
United States, Missouri | |
Saint Louis University School of Medicine | Active, not recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Columbia Univ | Active, not recruiting |
New York, New York, United States, 10032 | |
Univ of Rochester Med Ctr | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Catherine Bunce 585-275-5744 catherine_bunce@urmc.rochester.edu | |
New York Blood Ctr / Union Square | Recruiting |
New York, New York, United States, 10003 | |
Contact: Kent Curtis 212-388-0008 kcurtis@nybc.org | |
United States, Rhode Island | |
Miriam Hosp | Recruiting |
Providence, Rhode Island, United States, 02906 | |
Contact: Gail Yates 401-793-4335 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Kyle Rybczyk 615-322-5641 kyle.rybczyk@mcmail.vanderbilt.edu | |
United States, Washington | |
Fred Hutchinson Cancer Research Ctr | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Julie McElrath 206-667-6704 | |
Brazil | |
Hospital Escola Sao Francisco de Assis (HESFA) | Recruiting |
Cidade Nova, Brazil, 20210-303 | |
Contact: Regina Ferro Do Lago 55-21-227-39073 rlago@ax.apc.org | |
Peru | |
Impacta - Asociacion Civil Impacta Salud y Educaci | Recruiting |
Lima 18, Peru | |
Contact: Javier R Lama, MD + (51 1) 242 30 jrlama@impactaperu.org | |
Contact: Alberto Martin La Rosa, MD 011 511 242 3072 ext 122 alarosa@impactaperu.org | |
Peru, Loreto | |
Asociacion Civil Selva Amazonica | Recruiting |
Iquitos, Loreto, Peru | |
Contact: Juan Carlos Hinojosa 51 65 232 336 jhinojosa@impactaperu.org | |
South Africa | |
Perinatal HIV Research Unit, Chris Hani Baragwanat | Recruiting |
Bertsham, South Africa, 2013 | |
Contact: Nomathemba Mashego 27-11-989-9786 mashegot@hivsa.com | |
University of Cape Town. Institute of Infectious Diseases | Recruiting |
Mowbray, South Africa, 7705 | |
Contact: Surita Roux (272) 163-39735 surita.roux@hiv-research.org.za | |
Principal Investigator: Linda-Gail Bekker, MD | |
South Africa, North West Province | |
KOSH District HVTU | Recruiting |
Klerksdorp, North West Province, South Africa, 2571 SF | |
Contact: Mampedi Bogoshi 27-18-406-4230 Mbogoshi@aruminstitute.org | |
Principal Investigator: Gavin Churchyard, MD, PhD |
Study Chair: | Connie Celum, MD | University of Washington |
Study Chair: | Scott Hammer, MD | Columbia University |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HVTN 403 |
Study First Received: | January 24, 2002 |
Last Updated: | December 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00029913 |
Health Authority: | United States: Federal Government |
Placebos AIDS Vaccines CD4 Lymphocyte Count |
Disease Progression Viral Load HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Disease Progression Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |