- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00446979
Safety Study of UC-781 Vaginal Microbicide
Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Women and Acceptability in Their Male Partners,Chiang Rai, Thailand
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Chiang Rai, Tailandia, 57000
- Chiang Rai Health Club
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria for women:
- Age 18-50 years old
- Regular menses
- HIV-1 seronegative at screening
- Normal Pap smear at screening or documented normal Pap smear within six months prior to screening
- No evidence of reproductive tract infection (RTI)
- Willing and able to comply with study procedures, including pelvic exams, colposcopy, maintaining a study coital and symptom log, and applying assigned study gel per protocol
- Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit
Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
- Insertion of fingers and other objects into the vagina
- Receiving oral sex
- Receiving anal sex
- Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
- Using vaginal products other than the study gels, including douches, lubricants, or feminine hygiene products
- In a monogamous sexually active relationship with one male partner
- Report having vaginal intercourse only with that partner at least two times per week
- No other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Agree to use condoms for each act of vaginal intercourse during participation in the study
- Their male partner is informed and also consents to participate in the study
- Willing to have male partner informed and treated if an STD is diagnosed at screening or during the study
Inclusion Criteria for men:
- Age 18 years or older
- HIV-seronegative and free of other STI at screening exam
- One female sexual partner; no other reported partner in the prior six months and no plan to have another partner for the duration of the study
- Willing and able to comply with study procedures, including clinic visits, interviews and acceptability evaluation, and consistent use of condoms during enrollment in the study
- Willing to have female partner informed and treated if an STD is diagnosed at screening or during the study
Exclusion Criteria for women:
- Pregnancy or desire to become pregnant at time of study participation
- Currently breastfeeding
- Delivery or abortion within last eight weeks
History of any male sexual partner other than current partner in past six months
- No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including hematology, liver and kidney function
- History of post-coital vaginal bleeding in the past three months
- History of surgery to remove uterus or cervix
- History of surgery on the external genitalia, vaginal, or cervix in the past month
- Clinically significant chronic medical condition that is considered progressive, including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.
- History of sensitivity/allergy to latex
- Existence of a clinically detectable genital abnormality at screening (e.g. ulcer, congenital abnormality, any lesion with mucosal disruption)
- Concurrent participation in another trial of a vaginal product
- Have any other condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
Exclusion Criteria for men:
- History of genital surgery in the past month
- Clinical or laboratory evidence of an STI.
- History of sensitivity/allergy to latex
- History of any sexual partner other than their current partner in the past six months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
UC 781 0.1% carbomer gel
|
UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
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Experimental: 2
UC 781 0.25% carbomer gel
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UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
|
Comparador de placebos: 3
Placebo vaginal gel
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HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
Periodo de tiempo: 2 weeks
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2 weeks
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Symptoms of irritation
Periodo de tiempo: two weeks
|
two weeks
|
Changes in vaginal flora
Periodo de tiempo: Two weeks
|
Two weeks
|
Assessment of pro-inflammatory cytokines in the genital tract
Periodo de tiempo: Two weeks
|
Two weeks
|
Other product-related adverse events
Periodo de tiempo: Two weeks
|
Two weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
acceptability of UC-781 gel use
Periodo de tiempo: Two weeks
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Two weeks
|
systemic absorption of UC-781
Periodo de tiempo: Two weeks
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Two weeks
|
anti-HIV activity of genital secretions in the presence of UC-781 gel
Periodo de tiempo: Two weeks
|
Two weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sara J Whitehead, MD, MPH, Centers for Disease Control and Prevention
- Investigador principal: Chitlada Utaipiboon, MD, Thailand MOPH - U.S. CDC Collaboration
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes antirretrovirales
- UC-781
Otros números de identificación del estudio
- CDC-NCHHSTP-4744
- MOPH 109/2548
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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