 - Documentation of HIV-1 infection status, or confirmation of HIV-1 infection status if unknown or undocumented. Confirmation of HIV-1 infection is defined as positive results from two samples described in the protocol collected at different time points. All samples tested must be whole blood, serum, or plasma. As this study is being conducted under an IND, all test methods should be FDA-approved, if available. If FDA-approved methods are not available, test methods should be verified according to Good Clinical Laboratory Practice GCLP and approved by the IMPAACT Laboratory Center. More information on this criterion is available in the protocol. 