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


Phase 0
18 Years
N/A
Not Enrolling
Both
HIV Positive Allogeneic Bone Marrow Transplant

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Trial Information

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


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.

Inclusion Criteria


Inclusion Criteria

1. 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.

2. Patients must be ≥ 18 years of age.

3. Plan to undergo one of the following types of transplant, using bone marrow from a
related donor:

1. Myeloablative, HLA matched or partially HLA-mismatched (haploidentical),
related-donor bone marrow transplantation that includes high-dose
posttransplantation Cy

2. Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone
marrow transplantation that includes high-dose posttransplantation Cy

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT

Outcome Description:

Failure to maintain anti retroviral therapy for 24 hours

Outcome Time Frame:

24 hours

Safety Issue:

No

Principal Investigator

Richard Ambinder, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J1331

NCT ID:

NCT01836068

Start Date:

July 2013

Completion Date:

July 2017

Related Keywords:

  • HIV Positive Allogeneic Bone Marrow Transplant
  • HIV positive
  • Bone Marrow Transplant
  • Allogeneic BMT
  • BMT
  • HIV Seropositivity

Name

Location
The Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland  21231