Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir

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

Keywords

ClinConnect Summary

In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Serologically documented HIV infection.
• • Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
• • Parental consent for patients under 18.
• Nelfinavir-Failure Group:
• • Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
• • Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
• Control Group:
• • Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
• • Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.
• • Exclusion Criteria
• Prior Medication:
• Excluded:
• Control group:
• • Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
• Required:
• Nelfinavir-failure patients:
• • At least 16 weeks of nelfinavir.
• Control group:
• • At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.