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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836068
Recruitment Status : Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Condition or disease Intervention/treatment Phase
HIV Drug: Enfuvirtide Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
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
Actual Study Start Date : June 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Number of copies of HIV-1 DNA in blood mononuclear cells at baseline [ Time Frame: Baseline ]
    Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.

  2. Number of copies of HIV-1 DNA in blood mononuclear cells at 12 weeks [ Time Frame: 12 weeks post-intervention ]
    Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.

  3. Number of copies of HIV-1 DNA in blood mononuclear cells at 24 weeks [ Time Frame: 24 weeks post-intervention ]
    Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.

  4. Number of copies of HIV-1 DNA in blood mononuclear cells at 36 weeks [ Time Frame: 36 weeks post-intervention ]
    Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.

  5. Number of copies of HIV-1 DNA in blood mononuclear cells at 52 weeks [ Time Frame: 52 weeks post-intervention ]
    Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.

  6. Number of copies of HIV-1 DNA in blood mononuclear cells at 2 years [ Time Frame: 2 years post-intervention ]
    Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.


Other Outcome Measures:
  1. The incidence of acute graft-vs-host disease [ Time Frame: 2 years post-intervention ]
    Describe the incidence of acute graft-vs-host disease via the Keystone criteria

  2. The severity of acute graft-vs-host disease [ Time Frame: 2 years post-intervention ]
    Describe the severity of acute graft-vs-host disease via the Keystone criteria

  3. The incidence of chronic graft-vs-host disease as defined by the NIH consensus criteria [ Time Frame: 2 years post-intervention ]
    Describe the incidence chronic graft-vs-host disease via the NIH consensus criteria.

  4. The incidence of chronic graft-vs-host disease as defined by the Seattle criteria [ Time Frame: 2 years post-intervention ]
    Describe the incidence chronic graft-vs-host disease via the Seattle criteria.

  5. The severity of chronic graft-vs-host disease as defined by the NIH consensus criteria [ Time Frame: 2 years post-intervention ]
    Describe the severity of chronic graft-vs-host disease via the NIH consensus criteria and the Seattle criteria

  6. The severity of chronic graft-vs-host disease as defined by the Seattle criteria [ Time Frame: 2 years post-intervention ]
    Describe the severity of chronic graft-vs-host disease via the Seattle criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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


Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Richard Ambinder, M.D., Ph.D. Johns Hopkins University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01836068    
Other Study ID Numbers: J1331
NA_00083734 ( Other Identifier: Johns Hopkins )
1P30AI094189-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
HIV positive
HIV-1
Bone Marrow Transplant
Allogeneic BMT
BMT
Additional relevant MeSH terms:
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Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents