- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00002184
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 100/mm3 and HIV-1 RNA Copy Numbers >= 5,000 Copies/Ml and Prior RTI Therapy But No Prior PI Therapy
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This protocol is a stratified, randomized, double-blind, dose-comparative study of the safety and efficacy of adefovir dipivoxil in combination with nelfinavir and saquinavir soft gel capsules (SGC) or adefovir dipivoxil in combination with nelfinavir or saquinavir SGC plus a nucleoside analog (zidovudine, lamivudine, or stavudine).
Patients will be randomized to adefovir dipivoxil with nelfinavir and saquinavir or adefovir dipivoxil with nelfinavir or saquinavir plus a nucleoside analog (zidovudine, lamivudine, or stavudine). Within each treatment arm, patients will be randomized to 1 of 2 doses of adefovir dipivoxil in a blinded manner. Patients randomized to receive a nucleoside analog will then be assigned to receive either zidovudine, lamivudine, or stavudine based upon their previous RTI therapy. A daily dose of L-carnitine will be administered to all patients.
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016
- Phoenix Body Positive
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California
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Los Angeles, California, Estados Unidos, 900951793
- UCLA CARE Ctr
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Los Angeles, California, Estados Unidos, 90036
- Krauss Med Partners / Dept of Research and Development
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San Francisco, California, Estados Unidos, 94114
- Davies Med Ctr
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Connecticut
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Greenwich, Connecticut, Estados Unidos, 06830
- Blick Med Associates
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20037
- George Washington Med Ctr
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Univ School of Medicine
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- Univ of Massachusetts Med Ctr
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New York
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Manhassett, New York, Estados Unidos, 11030
- North Shore Community Hosp
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74114
- Associates of Med and Mental Health
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Univ of Pennsylvania
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Rhode Island
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Pawtucket, Rhode Island, Estados Unidos, 02860
- Mem Hosp of Rhode Island
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Univ of Texas Southwestern Med Ctr of Dallas
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Ponce, Puerto Rico, 00731
- Hosp Regional de Ponce - Area Vieja
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Santruce, Puerto Rico, 00908
- San Juan AIDS Program
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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
Patients must have:
- Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture).
- An HIV-1 RNA plasma titer >= 5000 copies/ml within 14-21 days prior to the baseline visit.
- CD4 cell count >= 100 cells/mm3 within 14-21 days prior to the baseline visit.
- A minimum life expectancy of at least 1 year.
- Signed, informed consent from parent or legal guardian for those patients < 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
- Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit.
- Exhibiting evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting that may confer an inability to receive an orally administered medication.
- Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 4 weeks prior to baseline and are not anticipated to require systemic therapy during the study.
- Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements.
Patients with any of the following prior conditions are excluded:
- A new AIDS-defining event diagnosed within 1 month prior to baseline.
Significant history of peripheral neuropathy.
1. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
Ritonavir, indinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam.
1. Prior use of adefovir dipivoxil.
- Prior use of any antiretroviral protease inhibitor.
- Immunizations within 30 days of baseline.
- Antiretroviral vaccine therapy within 60 days of baseline.
- Treatment in the 4 weeks prior to baseline with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
- Any other investigational drug within 30 days prior to baseline.
- Any prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
Required:
Prior therapy for > 4 weeks with any licensed nucleoside analog inhibitor of HIV reverse transcriptase.
Patients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Doble
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
- Farmacoterapia, Combinación
- Inhibidores de la transcriptasa inversa
- Agentes Anti-VIH
- VIH-1
- Estavudina
- Lamivudina
- ARN viral
- La carga viral
- Síndrome de inmunodeficiencia adquirida
- Recuento de linfocitos CD4
- Zidovudina
- Inhibidores de la proteasa del VIH
- Nelfinavir
- Relación dosis-respuesta, fármaco
- Adenina
- Saquinavir
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
- Inhibidores de la proteasa
- Inhibidores del citocromo P-450 CYP3A
- Inhibidores de enzimas del citocromo P-450
- Inhibidores de la proteasa del VIH
- Inhibidores de la proteasa viral
- Lamivudina
- Zidovudina
- Estavudina
- Nelfinavir
- Adefovir
- Adefovir dipivoxil
- Saquinavir
Otros números de identificación del estudio
- 232E
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