HIV Infection Clinical Trial
Official title:
Effects of Repeated Infusions of Adoptively Transferred Syngeneic Lymphocytes on the Immune Systems of HIV-1 Infected Identical Twins
This study will evaluate the safety and immune system effects of infusing HIV-infected
patients with multiple doses of lymphocytes (white blood cells) from their non-infected
identical twin. It will determine whether the donated lymphocytes can improve immune
function and reduce viral load in the infected twin.
Identical twin pairs-one who is infected with HIV-1 and one who is negative for the
virus-may be eligible for this study. Candidates will be screened with blood tests, a
medical history and physical examination.
Both twin participants will receive a tetanus booster shot, if needed. The non-infected twin
will undergo apheresis to collect white blood cells. For this procedure, whole blood is
collected, similar to the procedure for donating a unit of blood from a needle in the arm.
The blood flows through a cell separator machine where the white cells are removed, and the
rest of the blood (red cells, plasma and platelets) is returned to the donor through a
catheter in the opposite arm.
The collected lymphocytes will be given intravenously (through a vein) to the infected twin
over a 60-minute period. This procedure-apheresis and infusions-will be repeated 4 days a
week to complete one cycle. The cycles will be repeated about every 8 weeks for 6 cycles
(about 1 year).
The infected twin will have blood samples drawn on the first day of each cycle, 2 weeks
after the beginning of each cycle, and 4 weeks after each cycle to evaluate immune status,
viral load and other safety parameters. The frequency of these blood tests may change as the
study progresses. The infected twin will also undergo apheresis immediately before each
cycle of infusions and one month later to test the white cells for certain immune features.
The number of apheresis procedures may be reduced as the study proceeds.
This phase I/II study will evaluate the safety, immunologic effects, and potential efficacy of repeated infusions of syngeneic lymphocytes obtained from HIV-1 seronegative identical twins given in the setting of maximum anti-retroviral therapy. Unfractionated lymphocytes from each seronegative twin will be obtained by lymphocytapheresis and directly transferred to the HIV-1 seropositive twin. Four separate lymphocytaphereses and transfers will be performed over one week, and this cycle may be repeated as frequently as every 8 weeks for a total of up to 6 cycles. The recipient twin will be monitored for general health status, immunologic improvement, depletions within the CD4+ T-cell repertoire, and HIV-1 viral load. ;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
Active, not recruiting |
NCT02663856 -
My Smart Age With HIV: Smartphone Self-assessment of Frailty
|
||
Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
Completed |
NCT02564341 -
Targeting Effective Analgesia in Clinics for HIV - Intervention
|
N/A | |
Active, not recruiting |
NCT02302950 -
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
|
N/A | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
Completed |
NCT02525146 -
Birmingham Access to Care Study
|
N/A | |
Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
Completed |
NCT01702974 -
Immune Reconstitution in HIV Disease (IREHIV)
|
Phase 2 |