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

Phase 2
18 Years
Open (Enrolling)
Human T-cell Leukemia Virus Type 1 Infection

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Trial Information

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.

Inclusion Criteria:

1. Documented HTLV-1 infection: documentation may be serologic assay (ELISA, Western
blot) and confirmed to be HTLV-1 rather than HTLV-2 by differential Western blot
(e.g. Genelabs Diagnostics HTLV Blot 2.4) or PCR.

2. Adequate hematologic function within 14 days before enrollment: ANC > 1000 cells/mm3,
platelet count > 75,000 cells/mm3.

3. Adequate hepatic function, transaminase < 3 times the upper limit of normal;
bilirubin < 2.0.

4. Creatinine < 2.0

5. Karnofsky Performance Status at least 70

6. Age at least 18.

7. Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

8. Female patients of child bearing potential must have a negative pregnancy test within
72 hrs of initiation of therapy. Female patients are either post-menopausal or
surgically sterilized or willing to use two acceptable methods of birth control
(i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide,
condom with spermicide, or abstinence) during the study. Male patients must agree to
use two acceptable methods for contraception for the duration of the study. Women
must avoid pregnancy and men avoid fathering children while in the study.

9. Inclusion of Women and Minorities: Both men and women and members of all races and
ethnic groups are eligible for this trial.

Exclusion Criteria:

1. Acute active infection requiring therapy. Chronic therapy with potentially
myelosuppressive agents is allowed provided that entry hematologic criteria are met.

2. Women who are pregnant or breastfeeding. Confirmation that the subject is not
pregnant must be established by a negative serum beta-human chorionic gonadotropin
(beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for post-menopausal or surgically sterilized women.

3. Patient has received other investigational drugs with 14 days before enrollment

4. Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effects of raltegravir on HTLV-1 provirus load in asymptomatic individuals

Outcome Description:

Measured by DNA PCR from peripheral blood mononuclear cell DNA at days 0, 1, 8, 15, 29, 43, and 56.

Outcome Time Frame:

8 wks

Safety Issue:


Principal Investigator

Lee Ratner, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

  • Human T-cell Leukemia Virus Type 1 Infection
  • Raltegravir
  • HTLV
  • Integrase
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell



Washington University School of MedicineSaint Louis, Missouri  63110
University of California, San FranciscoSan Francisco, California  94143