Table 1B.

Summary of the outcome measures of efficacy assessed in therapeutic HIV vaccine clinical trials with analytical treatment interruptions: inactivated HIV vaccines

Vaccine	Study design	Primary outcome measure(s)	Other relevant efficacy outcome measures	Main findings	References
Remune® (inactivated HIV-1 particles)	Open label, non-randomized, two-arm study (immunized vs. unimmunized)	Immunogenicity pVL	CD4 T cell count	Immunization-induced HIV-specific immune responses that correlated with CD4 T cell counts and with viral control during ATI.	[142]
Remune®+ART intensification with ddI, hydroxyurea and GM-CSF	Proof-of-concept, single-arm study	Immunogenicity Viral load decrease: the difference between the viral load plateaus of the first two ATIs	CD4 T cell count Percentage of CD4 T cells	Following ART intensification+Remune®, HIV-specific IFN-γ secretion increased between the first two of three ATIs, while viral load decreased significantly, although there was no correlation between these two observations.	[143]