Status:
COMPLETED
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant
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 maintai...
Eligibility Criteria
Inclusion
- 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
- Patients with a known history of enfuvirtide resistance will not be eligible for this trial.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01836068
Start Date
June 1 2013
End Date
June 5 2021
Last Update
November 23 2021
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287