Efficacy of Zidovudine Compared to Stavudine, Both in Combination with Lamivudine and Indinavir, in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine, Stavudine, or Protease Inhibitors (Novavir Trial)

DOI: 10.1128/AAC.46.6.1906-1913.2002

Article Figures & Data

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FIG. 1.
Kaplan-Meier estimates of the proportion of patients who did not reach the primary study endpoint (viral load of >5,000 copies/ml).
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FIG. 2.
Proportion of patients with serum HIV RNA levels of less than 500 copies/ml. Bars are 95% confidence intervals.
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FIG. 3.
Changes from baseline in the CD4 cell count during the 80 weeks of the study. Median values are shown. Bars are 25th and 75th percentiles. IQR, interquartile range.

TABLE 1.

Baseline characteristics of patients

TABLE 2.

Subject disposition

Reason subjects discontinued study drugs	No. of subjects (%)
Reason subjects discontinued study drugs	d4T-3TC-IDV	AZT-3TC-IDV
Before wk 80	15 (18)	24 (28)
Lost to follow-up	1 (1)	1 (1)
Death	2 (2)	0
Adverse events	7 (8)	11 (13)
Subject request	2 (2)	3 (4)
Virological failure	1 (1)	6 (7)
Physician decision	0	1 (1)
Other reason or unknown	2 (2)	2 (2)
During the extended follow-up	9 (16)	13 (22)
Lost to follow-up	0	1 (2)
Death	1 (2)	0
Adverse events	4 (7)	0
Subject request	0	4 (7)
Virological failure	0	0
Physician decision	3 (5)	2 (3)
Other reason or unknown	1 (2)	6 (10)

TABLE 4.

Multivariate relative risk for predicting virological failure

Variable	Relative risk (95% CI^a)	P value
Plasma HIV RNA level
<50 versus >50 copies/ml at wk 16	0.32 (0.13-0.77)	0.011
<50 versus >50 copies/ml at wk 24	0.25 (0.09-0.70)	0.008
Decrease from baseline to wk 24 in log copies/ml	0.47 (0.32-0.70)	<0.001
Presence of the T215Y/F mutation	0.39 (0.18-0.83)	0.015

TABLE 5.

Grade 3 or 4 laboratory toxicities according to treatment group