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PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.
SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.
Full description
Patients receive combination nevirapine/AZT or AZT alone. Patients are evaluated for virologic and immunologic activity at 3 and 6 months.
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Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of clinically important disease other than HIV infection, that may put patient at risk because of participation in this study.
Prior Medication:
Excluded:
Excluded within 4 weeks prior to study entry:
Required:
Chronic use of alcohol or drugs sufficient to impair study compliance.
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Data sourced from clinicaltrials.gov
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