Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals

This study is currently recruiting participants.
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01836068
First received: April 16, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant


Condition Intervention Phase
HIV
Drug: Enfuvirtide
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Failure to maintain anti retroviral therapy for 24 hours


Secondary Outcome Measures:
  • Measure copies of HIV-1 DNA in blood mononuclear cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells at baseline 12, 24, 36, and 52 weeks


Other Outcome Measures:
  • The incidence and severity of acute and chronic graft-vs-host disease [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Describe the incidence and severity of acute and chronic graft-vs-host disease


Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enfuvirtide monotherapy
Enfuvirtide 90 mg subcutaneously every 12 hours will be also be administered during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions with conditioning regimens in patients who require ritonavir-boosted PI containing ART regimens.
Drug: Enfuvirtide
Enfuvirtide 90 mg subcutaneously twice daily will be administered to all patients on day 3 and 4 post-transplant and during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions
Other Name: Fuzeon

Detailed Description:

Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic hematopoietic stem cell transplant (HSCT). The primary outcome is the fraction of patients who maintain any form of anti-retroviral therapy, including enfuvirtide monotherapy, through day 60 post-transplant. If patients are unable to take oral anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy this will be considered maintenance of ART. Failure to maintain ART will be defined as ≥ 24 hours without any anti-retroviral therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry. Alternatively, two HIV-1 RNA values > 200 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent may be used to document infection.
  • Patients must be ≥ 18 years of age.
  • Plan to undergo a Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:
  • Plan to undergo a Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:

Exclusion Criteria:

- Patients with a known history of enfuvirtide resistance will not be eligible for this trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01836068

Contacts
Contact: Richard Ambinder, M.D., PhD 410-955-8839 rambind1@jhmi.edu
Contact: Christine Durand, M.D. 410-502-1003 christinedurand@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Richard Ambinder, Md. PhD    410-955-8839    rambind1@jhmi.edu   
Contact: Christine Durand, MD    410-502-1003    christinedurand@jhmi.edu   
Principal Investigator: Richard Ambinder, MD, PhD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Richard Ambinder, M.D., Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01836068     History of Changes
Other Study ID Numbers: J1331, NA_00083734
Study First Received: April 16, 2013
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
HIV positive
HIV-1
Bone Marrow Transplant
Allogeneic BMT
BMT

Additional relevant MeSH terms:
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014