HIV Infections Clinical Trial
Official title:
Phase 3, Single Center, Controlled, Investigator-blinded, Randomized Matched Pair Design Study of CD4 Cell Recovery in HIV-1 Patients With Sustained Virologic Response Comparing Protease Inhibitor and Non-nucleoside Reverse Transcriptase Inhibitor Based Treatment Regimes
Therapy guidelines recommend the use of either the non-nucleoside reverse transcriptase
inhibitor (NNRTI) efavirenz or a ritonavir-boostered protease inhibitor (PI) plus 2
nucleoside reverse transcriptase inhibitors (NRTI) as first-line treatment regimes of HIV-1
infection. Recent clinical studies suggest potential advantages of NNRTI- over PI-based
regimes in therapy initiation due to lower rates of virologic failure and less metabolic
side-effects. In contrast, PI regimes were claimed to cause greater increases in CD4 cell
count than NNRTI regimes, which has been attributed to intrinsic antiapoptotic effects of
the PI. However, it is still unclear whether the immunological response to a PI-containing
regime is greater than to an NNRTI-containing regime, whether there is a difference in the
extent of reduction of apoptosis between PI and NNRTI regimes and whether a difference in
apoptosis is associated with a difference in CD4 cell recovery.
We conducted a controlled, long-term, random matched pair design study in HIV-1 infected
individuals under sustained virologic suppression to evaluate in head-to-head comparison the
clinical effects of a constant PI-based or NNRTI-based regime on CD4 cell recovery and the
underlying molecular, biochemical and functional mechanisms.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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