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

NCT00000789 | Completed Phase 2

• 2 other identifiers: ACTG 24011217
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 54

Brief Summary

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.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Stavudine

Interventions

Stavudine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (54)

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, 90801, United States

Location

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, 90095, United States

Location

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, California, 94609, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, 92093, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, 94143, United States

Location

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, 90502, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 80218, United States

Location

Univ. of Connecticut Health Ctr., Dept. of Ped.

Farmington, Connecticut, 06032, United States

Location

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, 06504, United States

Location

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, 20010, United States

Location

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Atlanta, Georgia, 30306, United States

Location

Cook County Hosp.

Chicago, Illinois, 60612, United States

Location

Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

Chicago, Illinois, 60612, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, 60637, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, 21201, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 02115, United States

Location

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, 02118, United States

Location

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, 01199, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, 01655, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

Cooper Univ. Hosp.

Camden, New Jersey, 08103, United States

Location

UMDNJ - Robert Wood Johnson

New Brunswick, New Jersey, 08903, United States

Location

St. Joseph's Hosp. & Med. Ctr. of New Jersey

Paterson, New Jersey, United States

Location

Children's Hospital at Albany Medical Center, Dept. of Peds.

Albany, New York, 12208, United States

Location

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

Brooklyn, New York, 11203, United States

Location

North Shore-Long Island Jewish Health System, Dept. of Peds.

Great Neck, New York, 11021, United States

Location

Schneider Children's Hosp., Div. of Infectious Diseases

New Hyde Park, New York, 11040, United States

Location

NYU Med. Ctr., Dept. of Medicine

New York, New York, 10016, United States

Location

Metropolitan Hosp. NICHD CRS

New York, New York, 10029, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Incarnation Children's Ctr.

New York, New York, 10032, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, 10037, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases

Chapel Hill, North Carolina, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christopher's Hosp. for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

Charleston, South Carolina, 29425, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105, United States

Location

Children's Med. Ctr. Dallas

Dallas, Texas, 75235, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

UW School of Medicine - CHRMC

Seattle, Washington, 98105, United States

Location

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

Bayamón, 00956, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 00936, Puerto Rico

Location

Related Publications (4)

• Kline MW, Fletcher CV, Federici ME, Harris AT, Evans KD, Rutkiewicz VL, Shearer WT, Dunkle LM. Combination therapy with stavudine and didanosine in children with advanced human immunodeficiency virus infection: pharmacokinetic properties, safety, and immunologic and virologic effects. Pediatrics. 1996 Jun;97(6 Pt 1):886-90.

  PMID: 8657531 BACKGROUND

• McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173

  BACKGROUND

• Kline MW, Van Dyke RB, Lindsey JC, Gwynne M, Culnane M, McKinney RE Jr, Nichols S, Mitchell WG, Yogev R, Hutcheon N. A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. AIDS Clinical Trials Group 240 Team. Pediatrics. 1998 Feb;101(2):214-20. doi: 10.1542/peds.101.2.214.

  PMID: 9445494 BACKGROUND

• Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

  PMID: 21037891 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Stavudine; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Kline M

  STUDY CHAIR

• Van Dyke R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 1998
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

PR (3); US (51)