Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load
About 5% of HTLV-1 infected individuals develop lymphoma or myelopathy. High levels of virus
replication are predictive of disease development. HTLV-1 exhibits lower levels of variation
than HIV-1, suggesting that drug resistance is less likely to occur. Raltegravir was shown
to inhibit HTLV-1 integration and replication in culture using concentrations achievable
with the approved dose used in HIV-1 infected patients. Currently, no treatment is
recommended for asymptomatic infected individuals.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effects of raltegravir on HTLV-1 provirus load in asymptomatic individuals
Measured by DNA PCR from peripheral blood mononuclear cell DNA at days 0, 1, 8, 15, 29, 43, and 56.
Lee Ratner, MD PhD
Washington University School of Medicine
United States: Institutional Review Board
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|University of California, San Francisco||San Francisco, California 94143|