Trial Information

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

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.