Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine

Patrocinadores

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

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

To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.

In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.

Descripción detallada

In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.

Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.

Estado general Completed
Fecha de Terminación October 1998
Fase Phase 2
Tipo de estudio Interventional
Inscripción 198
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Stavudine

Tipo de intervención: Drug

Nombre de intervención: Didanosine

Elegibilidad

Criterios:

Inclusion Criteria

Patients must:

- Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.

- Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody

- Have parent or legal guardian willing to sign a consent.

Prior Medication: Required:

- On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

- Intractable diarrhea or vomiting.

- Current clinical or laboratory Grade 3 or worse toxicities.

Concurrent Medication:

Excluded:

- Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.

- Chemotherapy for active malignancy.

Patients with any of the following prior conditions are excluded:

- Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.

- Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.

- Subjects who have had chemotherapy for active malignancy.

Prior Medication:

Excluded:

- Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.

Género: All

Edad mínima: 6 Months

Edad máxima: 10 Years

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance, California, 90502, United States
Univ. of Colorado Denver NICHD CRS | Aurora, Colorado, United States
Univ. of Connecticut Health Ctr., Dept. of Ped. | Farmington, Connecticut, 06032, United States
Connecticut Children's Med. Ctr. | Hartford, Connecticut, 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
Cook County Hosp. | 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
Children's Hospital of Michigan NICHD CRS | Detroit, Michigan, 48201, United States
UMDNJ - Robert Wood Johnson | New Brunswick, New Jersey, 08903, United States
NJ Med. School CRS | Newark, New Jersey, 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
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
Strong Memorial Hospital Rochester NY NICHD CRS | Rochester, New York, United States
SUNY Stony Brook NICHD CRS | Stony Brook, New York, United States
DUMC Ped. CRS | Durham, North Carolina, 27710, 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
Children's Med. Ctr. Dallas | Dallas, Texas, 75235, United States
Texas Children's Hosp. CRS | Houston, Texas, 77030, 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

May 2012

Fiesta responsable

Tipo: Sponsor

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

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov