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Report for Clinical Trial NCT00300573
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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).
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 ---