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

Conditions

HIV

Keywords

HIV positive, HIV-1, Bone Marrow Transplant, Allogeneic BMT, BMT

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.

Adam A. Capoferri, Andrew D. Redd, Christopher D. Gocke, Laura R. Clark, Thomas C. Quinn et al. (7 authors)

JAIDS Journal of Acquired Immune Deficiency Syndromes2021-11-103 citations

10.1097/qai.0000000000002862

Short Communication: Persistence of HIV After Allogeneic Bone Marrow Transplant in a Dually Infected Individual

Adam A. Capoferri, Andrew D. Redd, Christopher D. Gocke, Laura R. Clark, Richard F. Ambinder et al. (6 authors)

AIDS Research and Human Retroviruses2021-06-10

10.1089/aid.2021.0047

Allogeneic bone marrow transplantation with post-transplant cyclophosphamide for patients with HIV and haematological malignancies: a feasibility study.

Durand CM, Capoferri AA, Redd AD, Zahurak M, Rosenbloom DIS, Cash A, Avery RK, Bolaños-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.

2020-07-0712 citations

10.1016/s2352-3018(20)30073-4

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGEnfuvirtide

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

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

United States

Outcome results

None listed