HIV Disease Clinical Trial
Official title:
Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Antiretroviral Strategy in Persistently Non-adherent Children, Adolescents, and Young Adults Who Are Failing HAART and Have the M184V Resistance Mutation.
The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC)
alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV
infected children, adolescents and young adults. The study was to see if there were changes
in the HIV virus and if there were differences in immune function, viral load and medication
side effects between the two groups over 28 weeks. Participants were assigned to either take
3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28
weeks of this study, if the participant was randomized to the continue HAART arm, he/she was
not switched to a different or new, potentially suppressive HAART regimen, but continued on
the current failing HAART regimen. However, if continuing HAART, the participant might be
switched to a new regimen if their provider felt that it was clinically needed or the
participant met certain study endpoints (e.g., drop in CD4, increase in viral load).
At the end of 28 weeks, the participant had the choice of remaining on the assigned study
group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they
would be followed for another 24 weeks to compare the difference in immune function, viral
load and medication side effects between the different groups.
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]
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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