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. Author manuscript; available in PMC: 2020 May 1.
Published in final edited form as: Lancet HIV. 2019 Apr 15;6(5):e297–e306. doi: 10.1016/S2352-3018(19)30053-0

Figure 1. CONSORT Flow Diagram.

Figure 1.

This diagram displays the progression of participants through screening, enrollment, allocation, and follow-up in the RV397 parallel, randomised clinical trial of VRC01 40 mg/kg or placebo administered intravenously to participants who initiated antiretroviral therapy during acute HIV infection, using the standard recommended by the CONSORT Group. The study had a target enrollment of 24 participants, but enrollment was halted early because changes in VRC01 packaging and stability testing procedures introduced barriers to the importation of study product into Thailand. Twenty-three participants were enrolled, four were withdrawn prior to randomization because of the unavailability of study product in-country, and 19 were randomised with five assigned to the placebo arm and 14 to VRC01. One participant in the VRC01 arm experienced severe generalised urticaria during the first study infusion and did not complete the infusion or undergo treatment interruption. This participant was included in analyses of safety data but no other analyses. Eighteen participants completed at least one study product infusion, underwent treatment interruption, and were included in all analyses.