Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
- Registration Number
- NCT01836068
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- 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:
- Patients with a known history of enfuvirtide resistance will not be eligible for this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enfuvirtide monotherapy Enfuvirtide 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.
- Primary Outcome Measures
Name Time Method Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT 24 hours Failure to maintain anti retroviral therapy for 24 hours
- Secondary Outcome Measures
Name Time Method Number of copies of HIV-1 DNA in blood mononuclear cells at baseline 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 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 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 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 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 2 years post-intervention Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.
Trial Locations
- Locations (1)
The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States