Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions (Vac09)
8 de junio de 2010 actualizado por: Swedish Institute for Infectious Disease Control
Active Immunotherapy Against HIV During Highly Active Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with a novel topical application method to 12 chronically HIV-infected cART treated patients.
The HIV DNA plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C, rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients received placebo.
The immunization was performed during three cycles of 7 weeks of cART followed by four weeks of therapy interruption.
After the last cycle of cART the patients were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below 350/ mm3 at two time points.
Cellular and humoral immune responses, viral load and CD4+ T a cell count was analysed throughout the study.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Stockholm, Suecia, 1188
- South Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Aged between 18 and 60 years
- Female, who is documented infertile or in menopause since at least 1 year, or male, who are willing not father a child for the duration of the study.
- HIV infection detected by two serological and/or HIV plasma RNA tests
- On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months
- Current CD4 count above 400
- CD4 count nadir >200
- Viral isolate pre ART available is preferable but not mandatory
- Willing to consider stopping HAART repeatedly.
- Willing to conform to a low alcohol intake (maximum of one glass per day)
- Able to tolerate didanosine and hydroxyurea
- Willing to change their HAART to exclude NNRTI and stavudine
- Able to give informed consent
- Availability for follow-up for planned duration of the study
Exclusion Criteria:
- Patients with ongoing infection(s) other than HIV.
- Prior or current pancreatitis or history of alcohol abuse.
- Ongoing neuropathy and history of more than grade 1 neuropathy.
- History of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure.
- Sun or solarium exposure at the immunizing sites one month before or during the trial.
- Cortisone treatment, systemic or local at the immunizing sites, one month before or during the trial.
- Patients with signs of autoimmune diseases
- Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ul, platelets <150,000/ul and LFT > 5x upper limit of normal
- Patients on any immune modulating or investigational drug
- Anamnestic allergy to kanamycin, plasmid gene products
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: HIV DNA + Hydroxyurea
0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART.
Every immunization cycle was followed by four weeks of therapy interruption.
The patients also received 500 mg of hydroxyurea daily.
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0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART.
Every immunization cycle was followed by four weeks of therapy interruption.
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Experimental: HIV DNA
0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART.
Every immunization cycle was followed by four weeks of therapy interruption.
|
0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART.
Every immunization cycle was followed by four weeks of therapy interruption.
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Comparador de placebos: Placebo
PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART.
Every immunization cycle was followed by four weeks of therapy interruption.
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0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART.
Every immunization cycle was followed by four weeks of therapy interruption.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
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Safety and feasibility
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The safety and feasibility of dermal HIV-1 DNA vaccination will be evaluated by recording all medical events.
They will be graded as to their seriousness, severity and relationship to the immunization.
Plasma HIV-1 RNA levels and T-cell levels will be closely monitored.
In addition to this the patient's individual experience and quality of life will be assessed.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
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Treatment effects
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To evaluate whether dermal HIV-1 DNA vaccination can prolong periods without treatment in HIV-infected individuals.
This will be evaluated by structured treatment interruption with close monitoring of HIV viral load and CD4+ T cell counts
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2006
Finalización primaria (Actual)
1 de octubre de 2009
Finalización del estudio (Actual)
1 de diciembre de 2009
Fechas de registro del estudio
Enviado por primera vez
7 de junio de 2010
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2010
Publicado por primera vez (Estimar)
9 de junio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
9 de junio de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2010
Última verificación
1 de febrero de 2006
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- DermHIVImm
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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