Determination of HIV-1 Production by the Prostate
Colección de datos
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Resumen
Fecha de inicio: 1 de julio de 1997
Fecha en la que se inscribió al primer participante.Virus present in semen likely contributes substantially to the sexual transmission of HIV. However, the source of HIV in semen is unknown. Some evidence suggests that the prostate may be the source of at least some of the virus in semen. This study is designed to determine whether the prostate may serve as the source of virus in semen by comparing the concentration of HIV-1 RNA in semen donated normally, in semen obtained following prostatic massage, and in expressed prostatic secretions. Finding a source for semen HIV would provide important insights into several aspects of HIV sexual transmission. Since some drugs do not enter the prostate well, the finding that virus is produced in the prostate might suggest the prostate could serve as a reservoir for HIV, leading to the development of resistance to antiviral agents.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 35 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Hombre
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
HIV positive male. Willing and able to participate on study. Age greater than or equal to 18 years. Stable antiretroviral therapy for the preceding 4 weeks and judged likely to remain on stable therapy for the study. Patients with a history of vasectomy or orchiectomy may be admitted to the study, but the data obtained from those patients will be analyzed separately on a pilot basis. Able to provide informed consent. Clinically stable. No clinical or laboratory evidence of bacterial prostatitis. No clinical or laboratory evidence of genito-urinary tract infection. No history of prostatectomy. Absolute neutrophil count greater than 500/ul. Platelets greater than 50,000. Patient must not have had treatment within the prior 8 weeks with anti-androgens or estrogens. Stable therapy with anabolic steroids will be allowed. Patient must not have localized or systemic disease which would, in the opinion of the investigator(s), render the patient at risk following prostatic massage and/or the donation of semen.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Cancer Institute (NCI)
Bethesda, United StatesAbrir National Cancer Institute (NCI) en Google Maps