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

Johns Hopkins Medicine

Status and phase: Completed; Early Phase 1

Conditions: HIV

Treatments: Drug: Enfuvirtide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01836068

1P30AI094189-01A1 (U.S. NIH Grant/Contract)

NA_00083734 (Other Identifier)

J1331

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Enfuvirtide monotherapy

Experimental group

Description:

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.

Treatment:

Drug: Enfuvirtide