Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
Study Details
Study Description
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 |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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 Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- The incidence of acute graft-vs-host disease [2 years post-intervention]
Describe the incidence of acute graft-vs-host disease via the Keystone criteria
- The severity of acute graft-vs-host disease [2 years post-intervention]
Describe the severity of acute graft-vs-host disease via the Keystone criteria
- The incidence of chronic graft-vs-host disease as defined by the NIH consensus criteria [2 years post-intervention]
Describe the incidence chronic graft-vs-host disease via the NIH consensus criteria.
- The incidence of chronic graft-vs-host disease as defined by the Seattle criteria [2 years post-intervention]
Describe the incidence chronic graft-vs-host disease via the Seattle criteria.
- The severity of chronic graft-vs-host disease as defined by the NIH consensus criteria [2 years post-intervention]
Describe the severity of chronic graft-vs-host disease via the NIH consensus criteria and the Seattle criteria
- The severity of chronic graft-vs-host disease as defined by the Seattle criteria [2 years post-intervention]
Describe the severity of chronic graft-vs-host disease via the Seattle criteria
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Richard Ambinder, M.D., Ph.D., Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- J1331
- NA_00083734
- 1P30AI094189-01A1