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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01836068
First received: April 16, 2013
Last updated: March 20, 2014
Last verified: March 2014

April 16, 2013
March 20, 2014
July 2013
July 2016   (final data collection date for primary outcome measure)
Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Failure to maintain anti retroviral therapy for 24 hours
Same as current
Complete list of historical versions of study NCT01836068 on ClinicalTrials.gov Archive Site
Measure copies of HIV-1 DNA in blood mononuclear cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells at baseline 12, 24, 36, and 52 weeks
Same as current
The incidence and severity of acute and chronic graft-vs-host disease [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Describe the incidence and severity of acute and chronic graft-vs-host disease
Same as current
 
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals

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.

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
HIV
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
Other Name: Fuzeon
Experimental: Enfuvirtide monotherapy
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.
Intervention: Drug: Enfuvirtide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2017
July 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Richard Ambinder, M.D., PhD 410-955-8839 rambind1@jhmi.edu
Contact: Christine Durand, M.D. 410-502-1003 christinedurand@jhmi.edu
United States
 
NCT01836068
J1331, NA_00083734
Yes
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Richard Ambinder, M.D., Ph.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP