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A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection

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Science Translational Medicine  06 Dec 2017:
Vol. 9, Issue 419, eaan8848
DOI: 10.1126/scitranslmed.aan8848

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Single-arm trials can leave you hanging

Depending on the study restraints and goals, not all clinical trials include a randomized placebo group. This is often done to minimize risk to patients but can also impair interpretation of the results. When Sneller et al. embarked on their therapeutic HIV vaccine trial, they chose to include a placebo group to get a better understanding of how their vaccine affected viral rebound upon therapy interruption. The vaccine itself generated minimal T cell activation and did not induce protective responses. Somewhat surprisingly, a proportion of individuals in the placebo arm demonstrated sustained viral suppression, although they were no longer being treated. These results suggest that any future HIV intervention trials would benefit from the inclusion of a placebo arm.