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

NCT01620736 | Withdrawn Phase 2 DMC

• 1 other identifier: WashU201109171
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human T-cell Leukemia Virus Type 1 Infection

Keywords

Raltegravir; HTLV; Integrase

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Effects of raltegravir on proviral load in CD4+CD25+, CD4+CD25-, and CD8+ cell populations

  8 wks

• Effects of raltegravir on number of LTR circles and level of proviral RNA expression in PBMCs

  8 wks

• Effects of raltegravir on viral integrase gene or other viral sequence changes

  8 wks

• Effect of raltegravir on viral integration sites

  8 wks

• Tolerance of raltegravir in HTLV-1 infected individuals

  8 wks

Study Arms (1)

Raltegravir

EXPERIMENTAL

Treatment with raltegravir for 8 wks

Drug: Raltegravir

Interventions

Raltegravir DRUG

Raltegravir 400 mg po bid

Raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate hematologic function within 14 days before enrollment: ANC \> 1000 cells/mm3, platelet count \> 75,000 cells/mm3.
• Adequate hepatic function, transaminase \< 3 times the upper limit of normal; bilirubin \< 2.0.
• Creatinine \< 2.0
• Karnofsky Performance Status at least 70
• Age at least 18.
• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• 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.

You may not qualify if:

• Acute active infection requiring therapy. Chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic criteria are met.
• 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.
• Patient has received other investigational drugs with 14 days before enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Seegulam ME, Ratner L. Integrase inhibitors effective against human T-cell leukemia virus type 1. Antimicrob Agents Chemother. 2011 May;55(5):2011-7. doi: 10.1128/AAC.01413-10. Epub 2011 Feb 22.

  PMID: 21343468 BACKGROUND

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lee Ratner, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: June 15, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 24, 2018

Record last verified: 2018-01