Table 3.
Variable† | Survival*
(subjects with CD4 T cell counts below 200/μl blood)
|
|||
---|---|---|---|---|
0–400 days
|
0–800 days
|
|||
P | Relative risk of dying‡ | P | Relative risk of dying | |
Elevated plasma Trx (>30 ng/ml) | 0.0001 | 2.7 (1.6–5.2) | 0.0002 | 2.2 (1.4–3.3) |
NAC treated§ | 0.0004 | 0.3 (0.06–0.6) | 0.002 | 0.5 (0.3–0.8) |
CD4 T cell GSH (FACS GSB)¶ | 0.04 | 0.1 (0.02–0.9) | 0.01 | 0.1 (0.02–0.6) |
CD4 T cell count (/μl blood) | 0.3 | NS | 0.005 | 0.8 (0.7–0.9) |
Survival analysis (proportional hazard) computed from baseline until the indicated time. Whole model fit, P < 0.0001; χ2 = 32 and 33 for 400 and 800 days, respectively. The model is computed on the basis of a total of 64 subjects, with 38 subjects in the group with <30 ng/ml and 26 subjects in the group with ≥30 ng/ml. None of the other variables listed in Table 1 showed significant effects. Reverse transcriptase inhibitor usage was similar for subjects in all groups and did not show a significant effect on survival when entered as a covariate in the above model. Since protease inhibitors were introduced after the end of the monitoring period, none of the subjects received protease inhibitors during the observation period shown here.
Baseline values representing the average of 2–3 measurements taken within 1 month for each subject. CD4 T cell counts and CD4 T cell GSH levels were entered into the model as continuous variables; plasma Trx and NAC treatment were entered as categorical variables.
Relative risk of dying (risk ratio); 95% confidence interval is shown in parentheses. Risk ratios shown for CD4 T cells are computed per increase in 20 T cells/μl blood.
Twenty-two of 64 subjects in this study were treated with NAC during the 8-week placebo-controlled and/or the 6-month open-label segments of the NAC trial. Among the subjects not treated with NAC (n = 42), 8 were in the placebo trial arm and did not elect open label NAC, 34 were screened for trial entry but either entered and rapidly withdrew (n = 3) or did not enter. Only 6/31 subjects in this latter No-NAC group were refused trial entry for medical cause, i.e., because they had protocol-defined exclusions such as elevated liver enzymes or hematologic deficiencies. We include these 6 subjects in data reported in the table. There was very little difference in the values obtained when significance and other table entries were computed with these 6 subjects excluded.
B cell GSB was significant at the 0.04 level at 400 days and not significant at 800 days.