A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

Patrocinadores

Patrocinador principal: National Institute of Allergy and Infectious Diseases (NIAID)

Colaborador: Glaxo Wellcome
Bristol-Myers Squibb

Fuente National Institute of Allergy and Infectious Diseases (NIAID)
Resumen breve

PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children.

SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs.

At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.

Descripción detallada

At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.

Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.

Estado general Completed
Fecha de Terminación July 1998
Fase Phase 2
Tipo de estudio Interventional
Inscripción 230
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Stavudine

Tipo de intervención: Drug

Nombre de intervención: Zidovudine

Elegibilidad

Criterios:

Inclusion Criteria

Concurrent Medication:

Recommended:

- PCP prophylaxis.

Allowed:

- Immunoglobulin.

- Erythropoietin, G-CSF, and GM-CSF.

- Corticosteroids.

- Ethionamide or isoniazid for TB if no alternative is available.

- Pyridoxine (up to 50 mg/day) as vitamin supplement.

Patients must have:

- Symptomatic HIV infection.

- No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG).

- Consent of parent or guardian.

NOTE:

- Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted.

Prior Medication:

Allowed:

- Maternal immunomodulator or antiretroviral therapy (including during pregnancy).

- Antiretroviral therapy prior to 2 months.

- Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Current grade 3 or worse neuropathy / lower motor neuropathy.

- Other grade 3 or worse clinical or laboratory toxicities.

- Known intolerance to either AZT or d4T.

Concurrent Medication:

Excluded:

- Chemotherapy for active malignancy.

Patients with the following prior conditions are excluded:

- History of grade 3 or worse neuropathy/lower motor neuropathy.

Prior Medication:

Excluded:

- More than 6 weeks of prior antiretroviral or immunomodulator therapy.

- Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.

Género: All

Edad mínima: 3 Months

Edad máxima: 6 Years

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
Long Beach Memorial Med. Ctr., Miller Children's Hosp. | Long Beach, California, 90801, United States
Usc La Nichd Crs | Los Angeles, California, 90033, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles, California, 90095, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | Oakland, California, 94609, United States
UCSD Maternal, Child, and Adolescent HIV CRS | San Diego, California, 92093, United States
UCSF Pediatric AIDS CRS | San Francisco, California, 94143, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance, California, 90502, United States
Univ. of Colorado Denver NICHD CRS | Aurora, Colorado, 80218, United States
Univ. of Connecticut Health Ctr., Dept. of Ped. | Farmington, Connecticut, 06032, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease | New Haven, Connecticut, 06504, United States
Children's National Med. Ctr., ACTU | Washington, District of Columbia, 20010, United States
Howard Univ. Washington DC NICHD CRS | Washington, District of Columbia, 20060, United States
Univ. of Florida Jacksonville NICHD CRS | Jacksonville, Florida, 32209, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami, Florida, 33161, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases | Atlanta, Georgia, 30306, United States
Cook County Hosp. | Chicago, Illinois, 60612, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. | Chicago, Illinois, 60612, United States
Chicago Children's CRS | Chicago, Illinois, 60614, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago, Illinois, 60637, United States
Tulane/LSU Maternal/Child CRS | New Orleans, Louisiana, 70112, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | Baltimore, Maryland, 21201, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston, Massachusetts, 02115, United States
BMC, Div. of Ped Infectious Diseases | Boston, Massachusetts, 02118, United States
Baystate Health, Baystate Med. Ctr. | Springfield, Massachusetts, 01199, United States
WNE Maternal Pediatric Adolescent AIDS CRS | Worcester, Massachusetts, 01655, United States
Children's Hospital of Michigan NICHD CRS | Detroit, Michigan, 48201, United States
Cooper Univ. Hosp. | Camden, New Jersey, 08103, United States
UMDNJ - Robert Wood Johnson | New Brunswick, New Jersey, 08903, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey | Paterson, New Jersey, United States
Children's Hospital at Albany Medical Center, Dept. of Peds. | Albany, New York, 12208, United States
Bronx-Lebanon Hosp. IMPAACT CRS | Bronx, New York, 10457, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS | Brooklyn, New York, 11203, United States
North Shore-Long Island Jewish Health System, Dept. of Peds. | Great Neck, New York, 11021, United States
Schneider Children's Hosp., Div. of Infectious Diseases | New Hyde Park, New York, 11040, United States
NYU Med. Ctr., Dept. of Medicine | New York, New York, 10016, United States
Metropolitan Hosp. NICHD CRS | New York, New York, 10029, United States
Columbia IMPAACT CRS | New York, New York, 10032, United States
Incarnation Children's Ctr. | New York, New York, 10032, United States
Harlem Hosp. Ctr. NY NICHD CRS | New York, New York, 10037, United States
Univ. of Rochester ACTG CRS | Rochester, New York, 14642, United States
SUNY Stony Brook NICHD CRS | Stony Brook, New York, 11794, United States
SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse, New York, 13210, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases | Chapel Hill, North Carolina, United States
DUMC Ped. CRS | Durham, North Carolina, 27710, United States
The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia, Pennsylvania, 19104, United States
St. Christopher's Hosp. for Children | Philadelphia, Pennsylvania, 19134, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases | Charleston, South Carolina, 29425, United States
St. Jude/UTHSC CRS | Memphis, Tennessee, 38105, United States
Children's Med. Ctr. Dallas | Dallas, Texas, 75235, United States
Texas Children's Hosp. CRS | Houston, Texas, 77030, United States
UW School of Medicine - CHRMC | Seattle, Washington, 98105, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. | Bayamon, 00956, Puerto Rico
San Juan City Hosp. PR NICHD CRS | San Juan, 00936, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS | San Juan, 00936, Puerto Rico
Ubicacion Paises

Puerto Rico

United States

Fecha de verificación

March 2012

Fiesta responsable

Tipo: Sponsor

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

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Fuente: ClinicalTrials.gov