These two randomised double-blind vehicle-controlled trials provide good evidence for the superiority of 0-1% alitretinoin gel over vehicle gel in the treatment of cutaneous AIDS-related KS. The overall response rate, using standard ACTG criteria, for 0-1% alitretinoin gel (applied twice daily for 12 weeks) was between 35% and 37%. Response rates in the vehicle-only groups were between 7% and 18%, suggesting that KS can undergo some degree of spontaneous remission or that the application of a vehicle alone may be of some benefit. This observation underlines the need to consider including suitable placebo groups in further trials.
We found no systematic reviews or large RCTs of antiretroviral therapy as a systemic treatment for AIDS-related KS. One small RCT of oral zidovudine, intravenous zidovudine or oral placebo in AIDS-related KS was identified but zidovudine monotherapy is no longer standard treatment for HIV infection.80 A small prospective cohort study and one larger retrospective cohort study examining the effect of HAART were found.81,82
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