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.
Interventional
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.
8 wks
No
Lee Ratner, MD PhD
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
WashU201109171
NCT01620736
January 2012
December 2014
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
University of California, San Francisco | San Francisco, California 94143 |