Randomized, Double-Blind
|
| Reference |
Population |
N |
AZT |
Acyclovir |
Follow-up |
Survival Outcome |
| Cooper et al., 1993 |
AIDS, median CD4 33 (AZT), 30 (combo) |
131 |
250 mg 4X daily |
800 mg 4X daily |
up to 1 year |
One year estimated survival was 0.73 vs 0.54, P = 0.014* |
|
|
ARC, median CD4 166 (AZT), 193 (combo) |
134 |
250 mg 4X daily |
800 mg 4X daily |
up to 1 year |
One year estimated survival was 0.97 vs 0.81, P = 0.045* |
| Youle et al., 1994 |
CDC stage IV disease, median CD4 6 (open), 41 (combo) |
302 |
open label therapy |
800 mg 4X daily |
means: 259 d (open), 274 d (combo) |
43 deaths (open) vs. 27 deaths (combo). Estimated 1 year mortality probability 0.39 vs 0.23, P = 0.018. In Cox model RH was 0.54 (combo/open), P = 0.013. |
| Saag et al., submitted |
Early symptomatic, CD4 >200 |
767 |
100 mg 6X daily |
800 mg 6X daily |
up to 96 weeks |
Death rate too low for analysis (3 deaths on AZT and 1 on combo) |
Analysis of Observational Data
|
| Stein et al., 1994 |
Starting AZT prior to development of AIDS, mean CD4 319 to 369 |
786 |
open label therapy |
median 600-800 mg in the HIV indication group |
up to 6 years, median 3 years |
In the time-dependent, intent-to-treat Cox model, ACV any indication RH = 0.74, P=0.07; ACV HIV indication RH = 0.64, P = 0.01. Estimated length of additional time to 90% survival between 154-210 d. No dose effect. Survival associated with longer uninterrupted therapy and initiation post-AIDS diagnosis. |
|
