HIV Infection Clinical Trial
Official title:
The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient
Main objective :
To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever
Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative
individuals who had not been given YFV before.
Secondary objectives :
- To develop and assess ELISPOT technology for yellow fever and to measure the response
within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects
and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy
(HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months)
in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3)
neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference
method) and a new pseudotype based method, (4) post-vaccination viremia and (5)
diversity of viral quasi-species.
- To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and
viral load.
Method :
Clinical Trial Phase III, Multicentre protocol at Saint-Louis hospital, Bichat hospital and
Cochin-Pasteur hospital, with CERVI, INSERM U 941 and SC10 collaboration.
Trial treatment : Yellow fever vaccination (STAMARIL)
Criterion :
Immuno-virologic: At J-7, J7, J28, M3 and M12 will be determined the levels of antibodies by
fluorescence, at J0, J7, J28, M3 and M12 titles and neutralization with Prnt pseudotypes, the
ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide
sequences on phylogenetic strains of viremia. Titles and Amariles kinetics of viremia,
neutralizing antibodies and ELISPOT will be considered as surrogate markers of response in
terms of groups.
Clinical and biological tolerance: At all follows up will be measured the incidence of CDC
classification events (for HIV+) and general and local reactions of degree ≥ 2 in the setting
of the injection of STAMARIL®.
Schedule :
Date of first enrolment : third quarter 2011. Inclusion period : 18 months. For each subject,
participation in this trial will be for 12 months.
;
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 |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
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 | |
Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
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 | |
Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
Completed |
NCT01680094 -
Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART
|
Phase 1/Phase 2 |