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Drugs that inhibit Tat -- an HIV protein essential for replication -- have performed well in vitro, leading to much initial excitement. The first candidate in this class, Ro 24-7429, was brought to trial quickly. But based on this negative study, further development was halted.
ACTG 213 randomized 96 patients to receive one of three dosages of Ro 24-7429 or a nucleoside analog (AZT or ddI) for 12 weeks. Most patients were already taking AZT or ddI and stopped therapy for at least four weeks before randomization. Initial CD4 counts ranged from 50 to 500; 55% of patients had a prior AIDS-defining condition, whereas 28% were asymptomatic.
At week 12, the nucleoside group had an average gain of 12 CD4 cells/mm3, versus a loss of 38 in the three T…