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

This study is currently recruiting participants.
Verified May 2017 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01836068
First Posted: April 19, 2013
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  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 Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    Describe the incidence and severity of acute and chronic graft-vs-host disease


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2020 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01836068     History of Changes
Other Study ID Numbers: J1331
NA_00083734 ( Other Identifier: Johns Hopkins )
First Submitted: April 16, 2013
First Posted: April 19, 2013
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents