The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection

Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001

Keywords

ClinConnect Summary

It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will result in:

1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in 50% of patients who have undetectable viral RNA by the most sensitive validated assay available (ultradirect assay) for at least 48 weeks.
2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the limit of detection of the ultradirect assay for at least 48 weeks in at least 25% of patients.
3. Suppression of HIV-1 infection as measured by a decrease in serum v...

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Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • HIV-1 seropositive status.
• • CD4 count \>= 500 cells/mm3.
• • Serum viral RNA level \> 1000 copies/ml.
• • Exclusion Criteria
• Prior Medication:
• Excluded:
• • Previous antiretroviral therapy.