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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01620736
• Date of registration: 25/01/2012
• Prospective Registration: No
• Primary sponsor: Washington University School of Medicine
• Public title: Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load
• Scientific title: Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load
• Date of first enrolment: January 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01620736
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Lee Ratner, MD PhD
• Affiliation: Washington University School of Medicine

Key inclusion & exclusion criteria

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not part of normal medical care, with the understanding that consent may be withdrawn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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Human T-cell Leukemia Virus Type 1 Infection

Intervention(s)

Drug: Raltegravir

Primary Outcome(s)

Effects of raltegravir on HTLV-1 provirus load in asymptomatic individuals [Time Frame: 8 wks]

Secondary Outcome(s)

Effects of raltegravir on viral integrase gene or other viral sequence changes [Time Frame: 8 wks]

Tolerance of raltegravir in HTLV-1 infected individuals [Time Frame: 8 wks]

Effects of raltegravir on number of LTR circles and level of proviral RNA expression in PBMCs [Time Frame: 8 wks]

Effects of raltegravir on proviral load in CD4+CD25+, CD4+CD25-, and CD8+ cell populations [Time Frame: 8 wks]

Effect of raltegravir on viral integration sites [Time Frame: 8 wks]

Secondary ID(s)

WashU201109171

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.