- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00000791
A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the anti-HIV activity of these treatment regimens.
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483, administered three times daily. Treatment continues for 16 to 24 weeks. Per 07/19/94 amendment: At the end of 24 weeks, blinded treatment continues for an additional 4 weeks, at which time patients may receive open-label drug on an optional basis for 90 days.
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos
- Alabama Therapeutics CRS
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California
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Los Angeles, California, Estados Unidos, 90033
- USC CRS
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Palo Alto, California, Estados Unidos
- Stanford CRS
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San Francisco, California, Estados Unidos, 94110
- Ucsf Aids Crs
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Colorado
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Aurora, Colorado, Estados Unidos
- University of Colorado Hospital CRS
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Florida
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Miami, Florida, Estados Unidos
- Univ. of Miami AIDS CRS
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University CRS
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Chicago, Illinois, Estados Unidos, 60612
- Rush Univ. Med. Ctr. ACTG CRS
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Chicago, Illinois, Estados Unidos, 60640
- Weiss Memorial Hosp.
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Chicago, Illinois, Estados Unidos
- Cook County Hosp. CORE Ctr.
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Indiana
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Indianapolis, Indiana, Estados Unidos
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
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Indianapolis, Indiana, Estados Unidos
- Methodist Hosp. of Indiana
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Missouri
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Saint Louis, Missouri, Estados Unidos
- Washington U CRS
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Saint Louis, Missouri, Estados Unidos, 63112
- St. Louis ConnectCare, Infectious Diseases Clinic
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New York
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Buffalo, New York, Estados Unidos, 14260
- SUNY - Buffalo, Erie County Medical Ctr.
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New York, New York, Estados Unidos
- Beth Israel Med. Ctr. (Mt. Sinai)
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Rochester, New York, Estados Unidos
- Univ. of Rochester ACTG CRS
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- Unc Aids Crs
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Raleigh, North Carolina, Estados Unidos
- Wake County Health and Human Services CRS
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Ohio
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Cincinnati, Ohio, Estados Unidos
- Univ. of Cincinnati CRS
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos
- Hosp. of the Univ. of Pennsylvania CRS
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Washington
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Seattle, Washington, Estados Unidos, 98104
- University of Washington AIDS CRS
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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
Concurrent Medication:
Required:
- PCP prophylaxis (trimethoprim/sulfamethoxazole, dapsone, or aerosolized pentamidine) in patients with CD4 count <= 200 cells/mm3.
Allowed:
- Topical antifungal agents, ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections, as medically indicated.
- Maintenance therapy for Mycobacteria disease with isoniazid, ethambutol, rifampin, pyrazinamide, clofazimine, ciprofloxacin, clarithromycin, or rifabutin.
- Maintenance therapy for toxoplasmosis with pyrimethamine, sulfadiazine, or clindamycin.
- Maintenance therapy for herpes simplex virus with acyclovir at <= 1000 mg/day.
- Recombinant erythropoietin and G-CSF, if indicated.
- Antibiotics for bacterial infections.
- Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics.
Concurrent Treatment:
Allowed:
- Localized radiation therapy and limited intralesional therapy for cutaneous Kaposi's sarcoma.
Patients must have:
- Documented HIV infection.
- Per 07/19/94 amendment, one of the following:
- CD4 count 150 - 350 cells/mm3 within 60 days prior to study entry AND prior AZT for no more than 12 months cumulative (given with or without ddI or ddC).
- CD4 count 50 - 350 cells/mm3 within 60 days prior to study entry AND no prior antiretroviral therapy.
- MT-2 cell assay within 60 days prior to study entry.
NOTE:
- Minimal Kaposi's sarcoma is permitted.
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
- Malignancy other than minimal Kaposi's sarcoma.
Concurrent Medication:
Excluded:
- Antiretroviral therapies (other than study drug).
- Biologic response modifiers.
- Systemic corticosteroids for > 21 consecutive days.
- Foscarnet.
- Systemic cytotoxic chemotherapy for a malignancy.
Patients with the following prior conditions are excluded:
- History of cataracts.
- History of intolerance to AZT at <= 600 mg/day.
- Unexplained temperature >= 38.5 degrees C that persists for any 7 days within the 30 days prior to study entry.
- Chronic diarrhea (defined as >= 3 stools per day) that persists for any 15 days within the 30 days prior to study entry.
Prior Medication:
Excluded:
- More than 6 months (more than 12 months per 07/19/94 amendment) cumulative prior therapy with AZT.
- Prior induction or maintenance therapy with foscarnet.
- Any investigational drug within 30 days prior to study entry.
- Prior SC-49483 or SC-48334.
- Prior ddC, ddI, or stavudine (d4T) as monotherapy.
- Interferon or interleukin within 30 days prior to study entry.
- Prior non-nucleoside reverse transcriptase inhibitors (e.g., NVP, ATV).
- Systemic corticosteroids for > 21 consecutive days.
- Acute treatment for a serious infection or any opportunistic infection within 14 days prior to study entry.
- Prior combination therapy with AZT, ddI, and/or ddC within 30 days prior to study entry.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Doble
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Saag M
Publicaciones y enlaces útiles
Publicaciones Generales
- Johnson VA, Bassett RL, Stanley KE, Saag MS, Fischl MA. Predictors of syncytium-inducing viral phenotype in a phase II double-blind trial of SC-49483 plus ZDV vs. ZDV. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:102 (abstract no 205)
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 (Actual)
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
- 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
- ACTG 259
- 11236 (DAIDS-ES)
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.
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