Status
Completed
Phase
Early Phase 1
Enrollment
11
Locations
1
Results
Not posted
Publications
3
Study summary
To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant
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.
Interventions
DRUG
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
Timeline
First posted
Apr 19, 2013
Study start
Jun 2013
Primary completion
Jan 22, 2020
Study completion
Jun 5, 2021
Results posted
Not reported
Registry updated
Nov 23, 2021
Outcomes
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
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.
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.
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.
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.
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.
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.
Eligibility
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Publications
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