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Comparison of ddI Versus Zidovudine in HIV-Infected Patients

11 de marzo de 2011 actualizado por: National Institute of Allergy and Infectious Diseases (NIAID)

Comparison of 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine in Therapy of Patients With HIV Infection

To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts < 200 cells/mm3.

AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.

Descripción general del estudio

Estado

Terminado

Condiciones

Infecciones por VIH

Intervención / Tratamiento

Descripción detallada

AMENDED: 9/28/90 Patients are assigned to one of 2 treatments under a double-blind, randomly allocated, experimental design if their duration of prior AZT therapy is 0 to 16 weeks. (Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level, adjusted for weight, and followed as originally planned.) Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks. Original design: Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design. ddI will be administered at two dose levels.

It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter. This study continues for at least 18 months after the entry of the first subject.

Tipo de estudio

Intervencionista

Inscripción

1500

Fase

Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Estados Unidos
- California
  - Los Angeles, California, Estados Unidos, 900276016
    - Children's Hosp of Los Angeles/UCLA Med Ctr
  - Los Angeles, California, Estados Unidos, 90033
    - Los Angeles County - USC Med Ctr
  - Palo Alto, California, Estados Unidos, 94304
    - Palo Alto Veterans Adm Med Ctr / Stanford Univ
  - San Diego, California, Estados Unidos, 921036325
    - Univ of California / San Diego Treatment Ctr
  - Stanford, California, Estados Unidos, 94305
    - Stanford Univ School of Medicine
  - Sylmar, California, Estados Unidos, 91342
    - Olive View Med Ctr
  - Sylmar, California, Estados Unidos, 91342
    - Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
  - Torrance, California, Estados Unidos, 90502
    - Harbor UCLA Med Ctr
- Colorado
  - Denver, Colorado, Estados Unidos, 80262
    - Univ of Colorado Health Sciences Ctr
  - Denver, Colorado, Estados Unidos, 80262
    - Mountain States Regional Hemophilia Ctr / Univ of Colorado
- District of Columbia
  - Washington, District of Columbia, Estados Unidos, 20037
    - George Washington Univ Med Ctr
  - Washington, District of Columbia, Estados Unidos, 20009
    - Whitman - Walker Clinic
- Florida
  - Fort Lauderdale, Florida, Estados Unidos, 33316
    - G E Morey Jr
  - Miami, Florida, Estados Unidos, 331361013
    - Univ of Miami School of Medicine
- Illinois
  - Chicago, Illinois, Estados Unidos, 60611
    - Northwestern Univ Med School
  - Chicago, Illinois, Estados Unidos, 60612
    - Rush Presbyterian - Saint Luke's Med Ctr
  - Chicago, Illinois, Estados Unidos, 60612
    - Cook County Hosp
  - Hines, Illinois, Estados Unidos, 60141
    - Edward Hines Veterans Administration Hosp
- Indiana
  - Indianapolis, Indiana, Estados Unidos, 462025250
    - Indiana Univ Hosp
- Kansas
  - Wichita, Kansas, Estados Unidos, 67214
    - Univ of Kansas School of Medicine
- Louisiana
  - New Orleans, Louisiana, Estados Unidos, 70112
    - Louisiana Comprehensive Hemophilia Care Ctr
  - New Orleans, Louisiana, Estados Unidos, 70112
    - Louisiana State Univ Med Ctr / Tulane Med School
  - New Orleans, Louisiana, Estados Unidos, 70112
    - Tulane Univ School of Medicine
  - New Orleans, Louisiana, Estados Unidos, 70112
    - Charity Hosp / Tulane Univ Med School
- Maryland
  - Baltimore, Maryland, Estados Unidos, 21287
    - Johns Hopkins Hosp
- Massachusetts
  - Boston, Massachusetts, Estados Unidos, 02114
    - Harvard (Massachusetts Gen Hosp)
  - Boston, Massachusetts, Estados Unidos, 02118
    - Boston Med Ctr
  - Boston, Massachusetts, Estados Unidos, 02215
    - Beth Israel Deaconess - West Campus
  - Boston, Massachusetts, Estados Unidos, 02215
    - Beth Israel Deaconess Med Ctr
  - Springfield, Massachusetts, Estados Unidos, 01199
    - Baystate Med Ctr of Springfield
  - Worcester, Massachusetts, Estados Unidos, 01605
    - Med Ctr of Central Massachusetts
  - Worcester, Massachusetts, Estados Unidos, 01655
    - Univ of Massachusetts Med Ctr
- Minnesota
  - Minneapolis, Minnesota, Estados Unidos, 55455
    - Univ of Minnesota
- Nebraska
  - Omaha, Nebraska, Estados Unidos, 68105
    - Nebraska Regional Hemophilia Ctr
- New York
  - Bronx, New York, Estados Unidos, 10461
    - Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  - Bronx, New York, Estados Unidos, 10465
    - Jack Weiler Hosp / Bronx Municipal Hosp
  - Bronx, New York, Estados Unidos, 10467
    - Montefiore Med Ctr / Bronx Municipal Hosp
  - Bronx, New York, Estados Unidos, 10468
    - Bronx Veterans Administration / Mount Sinai Hosp
  - Buffalo, New York, Estados Unidos, 14215
    - SUNY / Erie County Med Ctr at Buffalo
  - Elmhurst, New York, Estados Unidos, 11373
    - City Hosp Ctr at Elmhurst / Mount Sinai Hosp
  - New York, New York, Estados Unidos, 10021
    - Cornell Univ Med Ctr
  - New York, New York, Estados Unidos, 10003
    - Beth Israel Med Ctr / Peter Krueger Clinic
  - New York, New York, Estados Unidos, 10016
    - Bellevue Hosp / New York Univ Med Ctr
  - New York, New York, Estados Unidos, 10021
    - Mem Sloan - Kettering Cancer Ctr
  - New York, New York, Estados Unidos, 10025
    - Saint Luke's - Roosevelt Hosp Ctr
  - New York, New York, Estados Unidos, 10029
    - Mount Sinai Med Ctr
  - Rochester, New York, Estados Unidos, 14642
    - Univ of Rochester Medical Center
  - Stony Brook, New York, Estados Unidos, 117948153
    - SUNY - Stony Brook
  - Syracuse, New York, Estados Unidos, 13210
    - SUNY / State Univ of New York
- North Carolina
  - Chapel Hill, North Carolina, Estados Unidos, 275997215
    - Univ of North Carolina
  - Durham, North Carolina, Estados Unidos, 27710
    - Duke Univ Med Ctr
  - Winston-Salem, North Carolina, Estados Unidos, 27103
    - Bowman Gray School of Medicine / Wake Forest Univ
- Ohio
  - Cincinnati, Ohio, Estados Unidos, 452670405
    - Holmes Hosp / Univ of Cincinnati Med Ctr
  - Columbus, Ohio, Estados Unidos, 432101228
    - Ohio State Univ Hosp Clinic
  - Toledo, Ohio, Estados Unidos, 43699
    - Med College of Ohio
- Pennsylvania
  - Hershey, Pennsylvania, Estados Unidos, 170330850
    - Milton S Hershey Med Ctr
  - Philadelphia, Pennsylvania, Estados Unidos, 19104
    - Univ of Pennsylvania
  - Pittsburgh, Pennsylvania, Estados Unidos, 15219
    - Hemophilia Ctr of Western PA / Univ of Pittsburgh
  - Pittsburgh, Pennsylvania, Estados Unidos
    - Univ of Pittsburgh Med School
- South Carolina
  - West Columbia, South Carolina, Estados Unidos, 29169
    - Julio Arroyo
- Tennessee
  - Knoxville, Tennessee, Estados Unidos, 37920
    - Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
- Texas
  - Galveston, Texas, Estados Unidos, 77550
    - Univ TX Galveston Med Branch
  - Houston, Texas, Estados Unidos, 77030
    - Hermann Hosp / Univ Texas Health Science Ctr
  - Houston, Texas, Estados Unidos, 77030
    - Texas Children's Hosp / Baylor Univ
- Utah
  - Salt Lake City, Utah, Estados Unidos, 84132
    - Univ of Utah School of Medicine
- Virginia
  - Hampton, Virginia, Estados Unidos, 23666
    - Dr Stephen L Green
- Washington
  - Seattle, Washington, Estados Unidos, 98105
    - Univ of Washington
- Wisconsin
  - Milwaukee, Wisconsin, Estados Unidos, 53215
    - Dr Brian Buggy
  - Milwaukee, Wisconsin, Estados Unidos, 53226
    - Milwaukee County Med Complex
  - Milwaukee, Wisconsin, Estados Unidos, 53233
    - Great Lakes Hemophilia Foundation
Puerto Rico
- - San Juan, Puerto Rico, 009275800
    - San Juan Veterans Administration Med Ctr

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria

Concurrent Medication:

Required:

Aerosolized pentamidine (300 mg every 4 weeks using a Respirgard II nebulizer). In the event of physiological intolerance, alternative prophylaxis may be: Trimethoprim / sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg/day.

Allowed:

Maintenance therapy for active AIDS defining opportunistic infections for patients with 9 to 47 weeks' experience with zidovudine (AZT).

Treatment of opportunistic infections with other than sulfonamide containing drugs:

Pyrimethamine and sulfadiazine or clindamycin for suppression of toxoplasmosis acquired after study entry; fluconazole or amphotericin B for suppression of cryptococcosis or ketoconazole for candidiasis.

Intravenous acyclovir for up to 10 days. Erythropoietin for patients under the relevant treatment IND. Analgesics, antihistamines, antiemetics, antidiarrheal agents for symptomatic therapy for toxicities.

Isoniazid (INH) if no other acceptable therapy is available.

Metronidazole may be used for single courses of therapy not to exceed 14 days within consecutive 90 day intervals. Note:

Ketoconazole and dapsone should be taken 2 hours before or 2 hours after taking ddI (amendment 5/20/91).

Concurrent Treatment:

Allowed:

Blood transfusions for hemoglobin toxicity.

Patients must:

Have a diagnosis of AIDS or advanced AIDS related complex (ARC), or per 8/09/90 amendment, asymptomatic HIV infection with CD4 count = or < 200 cells/mm3.
Be either naive to zidovudine (AZT) or have taken AZT for = or < 48 weeks.
Have ended treatment for acute Pneumocystis carinii pneumonia (PCP) at least 2 weeks before study entry. For patients with 2 months or less experience with AZT, PCP infection will be the single and only AIDS-defining infection and must have been within 120 days of study entry. Per amendment, other AIDS-defining conditions are allowed in the 8 weeks prior to study entry (for patients in the AZT stratum).Only one episode of PCP is permitted unless patient has > 2 months AZT experience in which case > 1 prior episode of PCP infection is allowed.
Not have experienced a major intolerance to AZT at doses of at least 500 mg if the patient was on AZT therapy for = or < 48 weeks. A major intolerance is defined as recurrent grade 3 or greater toxicity which results in discontinuation of drug.

Allowed:

Basal cell carcinoma.
In situ carcinoma of the cervix.
Occasional premature atrial or ventricular contraction.
Patients developing new opportunistic infections after study entry will remain on this protocol.
Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts < 300 cells/mm3.

Prior Medication:

Allowed:

Previous treatment with zidovudine (AZT) up to 48 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or diseases are excluded:

Kaposi's sarcoma (KS) with evidence of visceral disease or where KS requires chemotherapy; subjects with localized KS having CD4 counts = or > 200 cells/mm3.
AIDS-dementia complex = or > stage 2.
Prior history of acute pancreatitis within past 2 years or chronic pancreatitis.
Intractable diarrhea.
History of seizures within past 6 months or currently requiring anticonvulsants for control.
History of past or current heart disease.
Presence of a malignancy likely in the investigators opinion to require cytotoxic myelosuppressive chemotherapy during the expected course of this trial.

Concurrent Medication:

Excluded:

Oral acidifying agents.
Neurotoxic drugs. NOTE: If patients require therapy for PCP with IV pentamidine, study mediation is stopped.

Patients with the following are excluded:

Active AIDS defining events. Maintenance therapy for prior AIDS-defining opportunistic infections is permitted.
Intolerance to AZT at doses of 500 mg because of recurrent grade 3 toxicity or greater which resulted in discontinuation of drug.
Neoplasms not specifically allowed.
Previous enrollment in any study of ddI, ddC or d4T.
> 48 weeks of AZT therapy.
An opportunistic infection not adequately controlled with suppressive therapies allowed in the protocol.
Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance study therapy.
Life expectancy = or < 6 months.

Prior Medication:

Excluded:

Ganciclovir.
AZT for = or > 48 weeks.

Excluded within 14 days of study entry:

Erythropoietin (Eprex).

Excluded within 30 days of study entry:

Anti-HIV therapy other than AZT.
Biologic response modifiers.
Other investigational drugs.
Corticosteroids.
Neurotoxic drugs.

Excluded within 90 days of study entry:

Ribavirin.

Prior Treatment:

Excluded within 14 days of study entry:

Transfusion.

Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Institute of Allergy and Infectious Diseases (NIAID)

Colaboradores

Bristol-Myers Squibb

Investigadores

Silla de estudio: R Dolin

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

7 de diciembre de 2022

Finalización primaria (Actual)

1 de octubre de 1992

Finalización del estudio

7 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 1999

Primero enviado que cumplió con los criterios de control de calidad

30 de agosto de 2001

Publicado por primera vez (Estimar)

31 de agosto de 2001

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de marzo de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

11 de marzo de 2011

Última verificación

1 de enero de 2003

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

ACTG 116
070V1
ACTG 116-A
ACTG 116-B/117
AI454-008

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.

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. .