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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00083734 | Other Identifier | Johns Hopkins | |
| 1P30AI094189-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enfuvirtide monotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfuvirtide | 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 |
| 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 |
| 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 | Description | Time Frame |
|---|---|---|
| The incidence of acute graft-vs-host disease | Describe the incidence of acute graft-vs-host disease via the Keystone criteria | 2 years post-intervention |
| The severity of acute graft-vs-host disease | Describe the severity of acute graft-vs-host disease via the Keystone criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Ambinder, M.D., Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34753870 | Derived | Capoferri AA, Redd AD, Gocke CD, Clark LR, Quinn TC, Ambinder RF, Durand CM. Brief Report: Rebound HIV Viremia With Meningoencephalitis After Antiretroviral Therapy Interruption After Allogeneic Bone Marrow Transplant. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):297-302. doi: 10.1097/QAI.0000000000002862. | |
| 34107771 | Derived | Capoferri AA, Redd AD, Gocke CD, Clark LR, Ambinder RF, Durand CM. Short Communication: Persistence of HIV After Allogeneic Bone Marrow Transplant in a Dually Infected Individual. AIDS Res Hum Retroviruses. 2022 Jan;38(1):33-36. doi: 10.1089/AID.2021.0047. Epub 2021 Jul 5. |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077560 | Enfuvirtide |
| ID | Term |
|---|---|
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
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|
|
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 |
| 2 years post-intervention |
| The incidence of chronic graft-vs-host disease as defined by the NIH consensus criteria | Describe the incidence chronic graft-vs-host disease via the NIH consensus criteria. | 2 years post-intervention |
| The incidence of chronic graft-vs-host disease as defined by the Seattle criteria | Describe the incidence chronic graft-vs-host disease via the Seattle criteria. | 2 years post-intervention |
| The severity of chronic graft-vs-host disease as defined by the NIH consensus criteria | Describe the severity of chronic graft-vs-host disease via the NIH consensus criteria and the Seattle criteria | 2 years post-intervention |
| The severity of chronic graft-vs-host disease as defined by the Seattle criteria | Describe the severity of chronic graft-vs-host disease via the Seattle criteria | 2 years post-intervention |
| 32649866 | Derived | Durand CM, Capoferri AA, Redd AD, Zahurak M, Rosenbloom DIS, Cash A, Avery RK, Bolanos-Meade J, Bollard CM, Bullen CK, Flexner C, Fuchs EJ, Gallant J, Gladstone DE, Gocke CD, Jones RJ, Kasamon YL, Lai J, Levis M, Luznik L, Marr KA, McHugh HL, Mehta Steinke S, Pham P, Pohlmeyer C, Pratz K, Shoham S, Wagner-Johnston N, Xu D, Siliciano JD, Quinn TC, Siliciano RF, Ambinder RF. Allogeneic bone marrow transplantation with post-transplant cyclophosphamide for patients with HIV and haematological malignancies: a feasibility study. Lancet HIV. 2020 Sep;7(9):e602-e610. doi: 10.1016/S2352-3018(20)30073-4. Epub 2020 Jul 7. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |