Randomized, Double-Blind Study Comparing Dexelvucitabine (DFC) to Lamivudine (3TC) in Subjects With Resistance to NRTIs, PIs, and NNRTIs — DECLARE

HIV Infections Clinical Trial

Official title:
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

Status Terminated

Clinical Trial Summary

The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period. In addition to treatment with the new OBR, patients will be randomized to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96 weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication (i.e., DFC to 3TC or 3TC to DFC).

Clinical Trial Description

The study will compare the safety and efficacy of an investigational nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC) 200 mg once daily, to an approved NRTI, lamivudine (3TC) 300 mg once daily in treatment experienced patients with HIV that is resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them based on prior treatment history, and results of HIV genotype and phenotype performed during screening. In addition to the OBR patients will be randomized to receive at at one to one ratio DFC or 3TC in a blinded fashion. The OBR may include any approved HIV treatments except 3TC, FTC, ddI, d4T and ddC. Medications available through expanded access may also be available to selected patients. Treatment in the study will continue for up to 96 weeks with primary endpoints at 24 and 48 weeks of therapy. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch study medication (DFC to 3TC or 3TC to DFC). A total of 250 patients will be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00300573
Study type	Interventional
Source	Incyte Corporation
Contact
Status	Terminated
Phase	Phase 2
Start date	April 2006
Completion date	April 2006

View Details

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