Phase III Nonoxynol-9 and HIV Infection
Nonoxynol-9
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Prevención
Resumen
Intravaginal application of N-9 may help protect women from HIV and other STD infection. Low rates of condom use in sub-Saharan African populations, which constitute the majority of HIV infections, dictate the need for prophylactic methods women can control. This trial will be conducted in Zimbabwe and Malawi. The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo. Following the pilot study and prior to screening for enrollment in the Phase III trial, potential volunteers will participate in a 2-month behavioral counseling program that will encourage the use of condoms. Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study. Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months. Participants have a follow-up evaluation once a month; a pelvic exam and blood tests are performed every third month.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 4400 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria Volunteers may be eligible if they: Are HIV-negative. Are sexually active and expect to have vaginal intercourse at least twice a week during the study. Are willing to keep a diary of their sexual behavior and N-9 use. Are willing to have regular clinic visits including pelvic exams. Are at least 18 years old. Are female. Exclusion Criteria Volunteers will not be eligible if they: Have had a child or an abortion in the past 42 days. Are allergic to latex or N-9. Have genital sores. Have syphilis, chlamydia, gonorrhea, or trichomoniasis. Are enrolled in another study for a product like N-9. Expect to use another vaginal product other than N-9 during the study. Are pregnant.
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