- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00000915
An HIV Vaccine Preparedness Study
HIV Vaccine Preparedness Study
The purpose of this study is to estimate the rate at which a certain population becomes infected with HIV. The individuals examined in this study are people who are expected to take part in future studies of HIV vaccines and nonvaccine HIV prevention studies. This study also examines the chances of becoming HIV-positive based on certain risk factors under conditions that are similar to the conditions that would exist in HIV vaccine and non-HIV prevention studies.
Before studying the effectiveness of a potential HIV vaccine, it is important to learn about the range of HIV risk behaviors in the potential participants of these studies. The probability of HIV infection associated with these risk behaviors should also be examined. This study is designed to increase the ability of HIVNET to put into place HIV prevention trials, to increase the diversity of trial participants, and to target populations at highest risk for HIV infection.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Vaccine preparedness studies are necessary in order to prepare for launching preventive HIV vaccine efficacy trials. It is important to gather information on the risk of HIV infection among recruited populations, the extent and stability of HIV risk behaviors in these populations, and the risk of HIV infection associated with risk behaviors. This vaccine preparedness study is designed to expand the capacity of the HIVNET to implement HIV prevention trials, increase the diversity of its participant population, and further target populations at highest risk of HIV infection.
Participants complete a total of 6 scheduled study visits: 2 at baseline, 2 at follow-up 6 months later, and 2 at follow-up 12 months after enrollment. Participant risk behaviors and knowledge of and attitudes toward HIV vaccine and other HIV prevention trials are assessed at each time point. HIV infection status is tested by standard HIV ELISA and Western blot at follow-up, as well as at participant request throughout the study. Participants are instructed to recognize and report suspected primary HIV infection based on symptoms or high-risk exposures. HIV pre-test, risk reduction, and post-test counseling is provided in accordance with CDC standards of practice. Participants who become infected with HIV during the study are counseled and referred for medical and psychosocial services.
Tipo de estudio
Inscripción
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90059
- Los Angeles County / Health Research Assoc / Drew Med Ctr
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Univ of Illinois Hosp at Chicago
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins Univ
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New York
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Bronx, New York, Estados Unidos, 10456
- Bronx Lebanon Hosp Ctr
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Bronx, New York, Estados Unidos, 10456
- New York Blood Ctr
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New York, New York, Estados Unidos, 10016
- New York Univ Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Univ of Pennsylvania / HIVNET
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- Miriam Hosp
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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
Participants meet the following criteria:
- HIV-seronegative.
- Available for 6 months of the study. (Note:
- Participants who plan to move from one study location to another are eligible.)
- Willing and able to provide information for locator purposes.
- Report one or more of the following risk behaviors:
For men:
- Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
- Anal intercourse (receptive or insertive) with one or more other men in the last year.
For women:
- Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
- Having a current male sex partner who is infected with HIV.
- Having a current male sex partner who has injected drugs in the last 5 years.
- Having 5 or more male sex partners in the last year.
- Diagnosis of syphilis, chlamydia, gonorrhea, first episode herpes, pelvic inflammatory disease, and/or trichomoniasis in the last year.
- Exchange of sex for money or drugs in the last year.
- Use of crack cocaine in the last 12 months.
See General Inclusion Criteria for required risk behaviors.
Volunteers must be:
- HIV-positive through HIVNET testing or HIV-seronegative by EIA.
- Presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study.
- Willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose HIV serostatus.
- Willing to receive counseling and HIV testing (HIV-seronegative partners only).
- Willing to agree to be interviewed with their partner and individually.
- Willing to continue engaging in sex with their partner.
- Willing to participate in a couples-based condom promotion intervention.
- Willing and able to attend each scheduled intervention/follow-up study visit.
Exclusion Criteria
Co-existing Condition:
Persons with the following symptoms or conditions are excluded:
- An obvious psychological or psychiatric disorder that would preclude provision of informed consent or otherwise contraindicate study participation.
- Any condition which in the opinion of the principal investigator would interfere with achieving the study objectives.
Men at risk through anal intercourse only are excluded if they:
- Currently have a single HIV-seronegative partner with whom they have been in a mutually monogamous relationship for at least 2 years.
Men and women at risk through injection only are excluded if they:
- Have been participating in any methadone drug treatment program for at least the last 6 months.
- Currently obtain over 50 percent of needles/syringes for injection of drugs from a needle exchange program.
NOTE:
- Meeting the following extremely high injection risk criteria overrides the exclusion criteria for injection risk as outlined above:
- Using a needle or syringe after one or more known HIV-positive persons 2 or more times in the past 3 months.
- Using a needle or syringe after persons of unknown HIV status in the past 3 months provided the following two conditions are true:
- (1) report using a needle or syringe after someone else 2 or more different times in the past 3 months and (2) report using a needle or syringe after 3 or more different persons in the past 3 months. (This second criterion could be met in 3 episodes of injection with a single injection partner, if the participant used a needle or syringe after a different person each time. Alternatively, the criterion could be met in a single episode of injection, if the participant used a needle or syringe after 3 or more persons had used a single set of works.)
Concurrent Medication:
Excluded:
- Enrollment in an HIV vaccine trial, unless approval is obtained from the Data Management Committee Project Officer.
Risk Behavior:
- See General Exclusion Criteria for excluded risk behaviors.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Dave Metzger
- Silla de estudio: George Seage
Publicaciones y enlaces útiles
Fechas de registro del estudio
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
Otros números de identificación del estudio
- HIVNET D01
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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