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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014