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Report for Clinical Trial NCT00300573

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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).

NCT00300573 HIV Infections Human Immunodeficiency Virus
MeSH:HIV Infections Acquired Immunodeficiency Syndrome

1 Interventions

Name: Dexelvucitabine

Description: nucleoside inhibitor of HIV Reverse Transcriptase
Type: Drug
Group Labels: 2

Dexelvucitabine (DFC) lamivudine (3TC)


Primary Outcomes

Measure: Percent of subjects with >= 1.0 log10 decrease in viral load from Baseline to Week 24 based on non-completer equals failure (NC=F)

Time: Week 48 compared to baseline

Measure: Percent of subjects at 48 weeks with sustained suppression of viral load >= 1.0 log10 below baseline as determined by time-to-loss of virological response (TLOVR)

Time: Week 48 compared to baseline

Secondary Outcomes

Measure: Median change in viral load from Baseline to Week 24 and to Week 48

Time: Week 24 or Week 48 compared to baseline

Measure: Proportion of subjects in each treatment arm with viral load reduction greater than the over all study median viral load reduction

Time: Week 24 and Week 48

Measure: Proportion of subjects with a viral load measurement <400 copies/mL at Week 24 and Week 48

Time: Week 24 and Week 48 compared to baseline

Measure: Proportion of subjects with a viral load measurement <50 copies/mL at Week 24 and Week 48

Time: Week 24 and Week 48 compared to Baseline

Measure: Median change in subset of T lymphocytes (CD4+) cell count from Baseline to Week 24 and Week 48

Time: Week 24 and Week 48 compared to baseline

Measure: Proportion of subjects with a 50% decrease and/or 100 cell/mm3 decrease in CD4+ cell count to Week 24 and to Week 48

Time: Week 24 and Week 48 compared to baseline

Measure: Proportion of subjects who "crossed-over" to receive treatment with the other blinded study medication

Time: Week 16 and visits thereafter

Measure: Number of Centers for Disease Control (CDC) Class C adverse events and deaths by treatment arm

Time: approximately every 2 to 4 weeks for laboratory testing

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q151M

- Subjects with RT mutations Q151M or T69SS on Screening genotype. --- Q151M ---



HPO Nodes