A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3

Patrocinadores

Patrocinador principal: Bristol-Myers Squibb

Fuente Bristol-Myers Squibb
Resumen breve

To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.

Estado general Completed
Fecha de Terminación December 1994
Fase N/A
Tipo de estudio Interventional
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Stavudine

Tipo de intervención: Drug

Nombre de intervención: Zidovudine

Elegibilidad

Criterios:

Inclusion Criteria

Concurrent Medication:

Allowed:

- AZT.

Patients must have:

- Documented HIV infection as determined by a positive ELISA and/or Western blot.

- Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.

- Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.

- Need for chronic systemic therapy at time of enrollment.

- Intractable diarrhea.

- Signs or symptoms of bilateral peripheral neuropathy at time of screening.

- Demonstrated intolerance to zidovudine therapy.

- Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements.

Concurrent Medication:

Excluded:

- Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction.

Patients with the following prior conditions are excluded:

- Prior history of bilateral peripheral neuropathy.

- Demonstrated intolerance to zidovudine therapy.

Prior Medication:

Excluded:

- Prior d4T, ddI, or ddC.

- Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).

- Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.

- Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.

Required:

- At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.

Género: All

Edad mínima: 13 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel
. ., . Principal Investigator
Ubicación
Instalaciones:
Univ of Arizona / Health Science Ctr | Tucson, Arizona, 85724, United States
East Bay AIDS Ctr | Berkeley, California, 94705, United States
Children's Hosp of Los Angeles | Los Angeles, California, 90027, United States
Combat Group | Los Angeles, California, 90028, United States
Los Angeles County - USC Med Ctr | Los Angeles, California, 90033, United States
Cedars Sinai Med Ctr | Los Angeles, California, 90048, United States
UCD Med Ctr / AIDS and Related Disorders Clinic | Sacramento, California, 95817, United States
Children's Hosp of San Francisco | San Francisco, California, 94118, United States
Harbor UCLA Med Ctr | Torrance, California, 90502, United States
Univ of Colorado Health Sciences Ctr | Denver, Colorado, 80262, United States
Whitman - Walker Clinic | Washington, District of Columbia, 20009, United States
George Washington Univ Med Ctr | Washington, District of Columbia, 20037, United States
Community Research Initiative of South Florida | Coral Gables, Florida, 33146, United States
TheraFirst Med Ctrs Inc | Fort Lauderdale, Florida, 33308, United States
Univ of Miami | Miami, Florida, 331016960, United States
Infectious Disease Research Institute Inc | Tampa, Florida, 33614, United States
Dr Steven Marlowe | Atlanta, Georgia, 30327, United States
Northwestern Univ Med School | Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr | Chicago, Illinois, 60612, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp | Indianapolis, Indiana, 46202, United States
Univ of Kansas School of Medicine / Univ Hosp | Kansas City, Kansas, 661607354, United States
Univ of Kansas School of Medicine | Wichita, Kansas, 672143124, United States
Chase Braxton Health Service | Baltimore, Maryland, 21201, United States
New England Deaconess Hosp | Boston, Massachusetts, 02215, United States
Univ of Nebraska Med Ctr / HIV Clinic | Omaha, Nebraska, 681985130, United States
Univ of New Mexico School of Medicine | Albuquerque, New Mexico, 87131, United States
Bronx Veterans Affairs Med Ctr | Bronx, New York, 10468, United States
Beth Israel Med Ctr | New York, New York, 10003, United States
Saint Luke's - Roosevelt Hosp Ctr | New York, New York, 10019, United States
Cornell Univ Med College | New York, New York, 10021, United States
Mount Sinai Med Ctr | New York, New York, 10029, United States
SUNY / Health Sciences Ctr at Stony Brook | Stony Brook, New York, 117948153, United States
Nalle Clinic | Charlotte, North Carolina, 28207, United States
Duke Univ Med Ctr | Durham, North Carolina, 27710, United States
Univ of Pennsylvania / HIV Clinic | Philadelphia, Pennsylvania, 19104, United States
Buckley Braffman Stern Med Associates | Philadelphia, Pennsylvania, 19107, United States
Montefiore Hosp | Pittsburgh, Pennsylvania, 15213, United States
Med Univ of South Carolina | Charleston, South Carolina, 29425, United States
Univ of Texas Southwestern Med Ctr of Dallas | Dallas, Texas, 75235, United States
Dr Edward Stool | Houston, Texas, 77004, United States
Houston Clinical Research Network | Houston, Texas, 77006, United States
Univ TX San Antonio Health Science Ctr | San Antonio, Texas, 782847881, United States
Univ of Utah School of Medicine | Salt Lake City, Utah, 84132, United States
Milwaukee County Med Complex | Milwaukee, Wisconsin, 53226, United States
UPR School of Medicine / San Juan Veterans Adm Med Ctr | San Juan, 009275800, Puerto Rico
Ubicacion Paises

Puerto Rico

United States

Fecha de verificación

August 2011

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov