- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00002048
The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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LaJolla, California, Estados Unidos, 92037
- LaJolla Veterans Administration Med Ctr
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San Diego, California, Estados Unidos, 92103
- AIDS Clinical Trials Group
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Georgetown Univ Med Ctr
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Florida
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Miami, Florida, Estados Unidos, 331361013
- Univ of Miami School of Medicine
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Tampa, Florida, Estados Unidos, 33612
- Univ of South Florida
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Georgia
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Atlanta, Georgia, Estados Unidos, 30303
- Emory Univ School of Medicine
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
- Univ of New Mexico Hlth Sciences Ctr / Dept of Med
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New York
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Manhasset, New York, Estados Unidos, 11030
- Northshore Hosp / Cornell Univ
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28207
- Nalle Clinic
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Winston Salem, North Carolina, Estados Unidos, 27103
- Bowman Gray School of Medicine / North Carolina Baptist Hosp
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Oregon
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Portland, Oregon, Estados Unidos, 97201
- Oregon Health Sciences Univ
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Portland, Oregon, Estados Unidos, 972103079
- Good Samaritan Hosp
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19146
- Graduate Hosp
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Buckley Braffman Stern Med Associates
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Med Univ of South Carolina
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38103
- Regional Med Ctr at Memphis
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Texas
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Galveston, Texas, Estados Unidos, 77550
- Univ TX Galveston Med Branch
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- Univ of Utah School of Medicine
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Salt Lake City, Utah, Estados Unidos, 84132
- Dr Kristen Reis
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Med College of Virginia
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Milwaukee County Med Complex
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
- Other significant, chronic underlying medical illness which would impair study completion.
- Liver dysfunction as demonstrated by lab results.
- Laboratory evidence of compromised bone marrow function.
Concurrent Medication:
Excluded:
- Any other experimental agents.
- Any probenecid-containing product.
Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:
- Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks.
- Unexplained fever > 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period.
- Unexplained diarrhea defined by = or > 2 liquid stools per day persisting for = or > 14 days or 15 days in any 30-day period.
- OR History of secondary infections associated with AIDS related complex (ARC) including:
- Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years.
- Herpes zoster infection within 3 years.
- Oral hairy leukoplakia at any time.
- OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS.
- Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I).
- Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment.
Prior Medication:
Excluded:
- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).
Excluded within 4 weeks of study entry:
- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.
Excluded within 3 months of study entry:
- Antiretroviral drugs or biologic response modifiers.
Excluded within 4 months of study entry:
- Systemic corticosteroids.
Patients must meet the following criteria:
- HIV infection demonstrated by ELISA and confirmed by Western blot.
- Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL).
- Ability to give informed consent.
- Willingness to be followed by the originating medical center for the entire 3-year duration of the study.
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
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
- Linfadenopatía
- Enfermedades linfáticas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la transcriptasa inversa
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes Anti-VIH
- Agentes antirretrovirales
- Antimetabolitos
- Zidovudina
Otros números de identificación del estudio
- 014J
- 21
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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-
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-
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