Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy

Currently, there is no clear consensus for managing virologic failure. Generally, failure of non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapy due to non-adherence is associated with high rates of NNRTI resistance, while failure of protease inhibitor (PI)-based therapy due to non-adherence carries a much lower risk of PI resistance. In the setting of incomplete adherence and virologic failure despite adherence education, an optimal strategy would be one that effectively bridges the period between the cessation of the failing regimen of highly active antiretroviral (ARV) therapy and initiation of a new HAART regimen. This would provide time for interventions to improve adherence to be effective while minimizing accumulation of additional drug resistance mutations. Given the compelling need for an effective bridging strategy, the limited evidence for the safety and efficacy of this bridging regimen, and the high level of acceptability of studying 3TC or FTC monotherapy as an effective alternative, P1094 proposed to conduct a randomized clinical trial (RCT) comparing use of 3TC or FTC monotherapy as a short-term bridging regimen vs. continuation of non-suppressive HAART in non-adherent subjects. This study closed early due to lack of accrual, with only 33 of the target 344 participants enrolled. Therefore analyses, including the analysis of the primary outcome, are descriptive. Only analyses for Step 1 could be done (Step 2 was observational). The following secondary analyses could not be performed: Changes in Genotypic HIV Drug Resistance From Baseline Changes HIV Replication Capacity \[Time Frame: 28 and 52 weeks\] Changes in CD4 Percent and CD4+ T Cell Count \[Time Frame: 52 weeks\] Changes in HIV-1 RNA Levels \[Time Frame: 52 Weeks\] Changes in Immune Activation \[Time Frame: 28 and 52 Weeks\] Number and Percent of Subjects With Adverse Clinical Outcomes \[Time Frame: 52 Weeks\] Adherence as Measured by 3-day Recall \[Time Frame: 52 Weeks\]