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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836068
• Other study ID #: J1331
• Secondary ID: NA_000837341P30A
• Status: Completed
• Phase: Early Phase 1
• Start date: June 2013
• Est. completion date: June 5, 2021

Study information

• Verified date: June 2021
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 5, 2021
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	The severity of acute graft-vs-host disease	Describe the severity of acute graft-vs-host disease via the Keystone criteria	2 years post-intervention
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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