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HPTN Central Laboratory Policy

Verification of HIV Infection Status of Study Subjects

In order to verify the HIV infection status of clinical trial participants, the HPTN Central Lab will perform the following testing as a quality assurance measure:

1.  Baseline plama/serum samples from 50 or ten percent of randomly selected enrolled adult subjects (whichever is greater) at each site will be retested for HIV antibody by the Central Laboratory using FDA licensed tests. Samples from all subjects will be retested if there are less than 50 total trial subjects. In the event of a false positive or false negative result which changes the infection status of the subject, an additional 100 or 20% of samples (whichever is greater) from enrolled subjects will be retested.
2. Baseline and seroconversion plasma/serum samples from all seroconverting adult subjects and an equal number of randomly selected samples from uninfected subjects will be retested by the Central Lab using FDA licensed tests (ie., HIV antibody, HIV DNA PCR or HIV RNA if necessary). In the event of false positive or false negative result, which changes the endpoint infection status of the subject, a sample from the last visit from all subjects will be retested.
3. Plasma/serum samples from all HIV infected infants in perinatal trials and an equal number of randomly selected uninfected infants will be retested by the Central Lab using FDA licensed tests (ie., HIV antibody, HIV DNA PCR or HIV RNA). In the event of false positive or false negative result which changes the endpoint infection status of the subject, a sample from the last visit from all subjects will be retested.