Clinical Trial: Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load
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 Summary: 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.
Sponsor: Washington University School of Medicine
Current Primary Outcome: Effects of raltegravir on HTLV-1 provirus load in asymptomatic individuals [ Time Frame: 8 wks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Effects of raltegravir on proviral load in CD4+CD25+, CD4+CD25-, and CD8+ cell populations [ Time Frame: 8 wks ]Measured by real time PCR with DNA from sorted peripheral blood mononuclear cell DNA at days 1, 8, 15, 29, 43, and 56.
- Effects of raltegravir on number of LTR circles and level of proviral RNA expression in PBMCs [ Time Frame: 8 wks ]
- Number of LTR circles measure by real time PCR on peripheral blood mononculear cell DNA at days 0, 1, 8, 15, 29, 43, and 56
- Level of Proviral RNA Expression in PBMCs measured by real time RT PCR on peripheral blood mononculear cell RNA at days 0, 1, 8, 15, 29, 43, and 56
- Effects of raltegravir on viral integrase gene or other viral sequence changes [ Time Frame: 8 wks ]Measured by automated sequence analysis of PCR amplified viral DNA obtained at days 0, 1, 8, 15, 29, 43, and 56
- Effect of raltegravir on viral integration sites [ Time Frame: 8 wks ]Measured by automated DNA analysis of oligonucleotide linked PCR amplified DNA from peripheral blood mononuclear cell DNA obtianed at days 0, 1, 8, 15, 29, 43,and 56
- Tolerance of raltegravir in HTLV-1 infected individuals [ Time Frame: 8 wks ]Assessed by physical exam, CBC, and serum chemistries on days 29 and 57 and
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: January 25, 2012
Date Started: January 2012
Date Completion: December 2014
Last Updated: June 14, 2012
Last Verified: June 2012