A Randomized, Double-Blind, Phase II Study Comparing the Anti-Retroviral Safety and Efficacy of Dexelvucitabine (DFC) 200 mg Once Daily to Lamivudine (3TC) 300 mg Once Daily in Addition to Optimized Background Therapy in HIV-1 Infected Subjects Who Have Failed and/or Harbor HIV with Resistance Mutations to NRTIs, PIs, and NNRTIs

Registry ID

EUCTR2006-000096-16

Source registry

EUCTR

Status

Completed

Phase

PHASE2

Sponsor

Incyte Corporation

Start date

2006-03-22

Completion date

2006-03-22

Last update

2026-08-16

Conditions

• HIV-1

Summary

• To compare the antiviral effect of a 200 mg DFC dose versus a 300 mg 3TC dose in addition to optimized background therapy (OBT) over 24 weeks and 48 weeks in treatment-experienced subjects who have failed and harbor virus with resistance mutations to NRTIs, PIs, and NNRTIs. • To assess the safety and tolerability of a 200 mg DFC dose in HIV-1 infected subjects.

Locations

• , , UK

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