In this non-randomized study, Dr. Rubio and colleagues looked at the efficacy and tolerance of combination therapy with AZT + 3TC + indinavir as compared to d4T + 3TC + indinavir. They enrolled forty-four pre-treated patients (either AZT and/or ddI and/or ddC, for a median period of just over two years). Patients had fewer than 200 CD4 cells, a viral load of at least 3000 copies/ml, and had never taken a protease inhibitor, d4T, or 3TC. Patient withdrawal because of side effects occurred with equal regularity on each arm (~12%).
Each drug combination proved to be effective, with no statistical difference between the study arms. On the d4T + 3TC + indinavir, which enrolled sixteen patients, the mean baseline CD4 cell count was 79 cells/mm3. By the week 16 point, which was reached by eight patients, the mean CD4 count had risen to 217 cells/mm3, and 7 of the 8 (87%) had achieved undetectable viral loads (<500 copies/ml).
For the twenty-eight patients on the AZT + 3TC + indinavir arm, mean CD4 count at baseline was 52, and had risen to 171 by week 16. Twenty-two patients reached week 16, and 18 of them (82%) were undetectable.
This small study concluded that both regimens have a similar effect in pre-treated patients.