Monotherapy/”Virtual” Monotherapy
While we recognize that there may be some situations, particularly in pharmacodynamic studies where a single agent must be used, wherever possible such studies should be done in HIV negative volunteers.
Where it is absolutely necessary to use HIV+ subjects, exposure to monotherapy or virtual monotherapy should be restricted to the shortest possible intervals.
This may be overly optimistic, but it would be very nice to see some kind of longer term follow-up to assess the risk of conducting such studies.