Status and phase
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About
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
Full description
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.
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Inclusion and exclusion criteria
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with any of the following prior conditions or symptoms are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Required:
At least 6 months of prior cumulative ZDV therapy.
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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