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View Clinical Trial (Medical Research Study)
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A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials - NCT00029913-02115B (Clinical Trial 114067)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy114067.aspx
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| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02115 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Fenway Community Health
Boston, MA 02115
United States |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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