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

Study Overview
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Brief Summary
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To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant

Detailed Description
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Drug: Enfuvirtide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enfuvirtide monotherapy<br>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<br>* 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<br>* Other names: Fuzeon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT | Failure to maintain anti retroviral therapy for 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of copies of HIV-1 DNA in blood mononuclear cells at baseline | Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells. | Baseline | 
| Number of copies of HIV-1 DNA in blood mononuclear cells at 12 weeks | Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells. | 12 weeks post-intervention | 
| Number of copies of HIV-1 DNA in blood mononuclear cells at 24 weeks | Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells. | 24 weeks post-intervention | 
| Number of copies of HIV-1 DNA in blood mononuclear cells at 36 weeks | Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells. | 36 weeks post-intervention | 
| Number of copies of HIV-1 DNA in blood mononuclear cells at 52 weeks | Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells. | 52 weeks post-intervention | 
| Number of copies of HIV-1 DNA in blood mononuclear cells at 2 years | Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells. | 2 years post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMT, HIV positive, Bone Marrow Transplant, Allogeneic BMT, HIV-1