Spots Global Cancer Trial Database for Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

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Trial Identification

Brief Title: Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

Official Title: Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

Study ID: NCT01620736

Conditions

Human T-cell Leukemia Virus Type 1 Infection

Interventions

Raltegravir

Study Description

Brief Summary: This is a study of the effect of raltegravir on human T-cell leukemia virus type 1 (HTLV-1) viral load in asymptomatic patients. The study will enroll 14 subjects for a period of 2 months of treatment and 1 month of followup. The study will assess the effect of raltegravir on virus load in peripheral blood lymphocytes, level of virus gene expression, and sites of viral integration.

Detailed Description: 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.