Table 1.

Secondary Endpoints of the HPTN 052 Study

Endpoint	Measurements
Morbidity and mortality of index case	Time from enrollment to time of first occurrence of any HIV/AIDS-related event (see Appendix IV for qualifying events) or death (all causes) Time from enrollment to death (all causes) Time from enrollment to time of first occurrence of any HIV/AIDS-related event or WHO disease Stage 2 or 3 (see Appendix IV for qualifying events) Time from enrollment to time of first occurrence of any other targeted medical condition (see Appendix IV for qualifying events) Time from enrollment to time of occurrence of any condition outlined in Appendix IV or death
Immunologic response of index case	CD4+ cell count over time Time from enrollment to immunologic failure. (Immunologic failure is defined as two consecutive measurements of CD4+ cell count at or below the range of 200–250 cells/mm3, or develops an AIDS-defining illness) Time from initiation of ART to immunologic failure Time from initiation of secondary regimen to immunologic failure
Virologic response of index case	Blood plasma HIV-1 RNA level over time Seminal plasma HIV-1 RNA levels over time in males Cervical vaginal HIV-1 RNA levels over time in females Time from initiation of the starting regimen to confirmed virologic failure Time from initiation of secondary regimen to confirmed virologic failure
Initiation of secondary regimen Safety and toxicity of treatment	Time to initiation of secondary regimen (any reason) Time from enrollment to time of first development and any subsequent occurrence of Grade 3 or 4 ART-related toxicities Time from enrollment to time of first serious cardiovascular or other metabolic events (Grade 4 and higher) Time from enrollment to time of first Grade 4 and higher events (any event)
HIV drug resistant virus	Prevalence of drug resistant HIV virus Proportion of infected partners acquiring a drug resistant HIV virus
Incidence of STDs in index case and partners	Time from enrollment to the time of first development and subsequent development of STDs
Adherence in index case	Adherence to all treatment over time Adherence to treatment over time following initiation of antiretroviral therapy starting regimen Adherence to treatment over time following initiation of an antiretroviral therapy secondary treatment regimen
Sexual behavior of index cases on ART, and their partners	Sexual behavior over time following initiation of starting regimen Sexual behavior over time following initiation of a secondary regimen
Quality-of-Life indicators of index case	Quality-of-Life indicators over time following initiation of starting regimen Quality-of-Life indicators over time following initiation of a secondary regimen