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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Stavudine
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Stavudine

Eligibility Criteria

3 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Usc La Nichd Crs
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • UCSF Pediatric AIDS CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Colorado Denver NICHD CRS
  • Univ. of Connecticut Health Ctr., Dept. of Ped.
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Children's National Med. Ctr., ACTU
  • Howard Univ. Washington DC NICHD CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Cook County Hosp.
  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
  • Chicago Children's CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Tulane/LSU Maternal/Child CRS
  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Children's Hospital of Michigan NICHD CRS
  • Cooper Univ. Hosp.
  • UMDNJ - Robert Wood Johnson
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • Children's Hospital at Albany Medical Center, Dept. of Peds.
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • North Shore-Long Island Jewish Health System, Dept. of Peds.
  • Schneider Children's Hosp., Div. of Infectious Diseases
  • NYU Med. Ctr., Dept. of Medicine
  • Metropolitan Hosp. NICHD CRS
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Univ. of Rochester ACTG CRS
  • SUNY Stony Brook NICHD CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • St. Christopher's Hosp. for Children
  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
  • St. Jude/UTHSC CRS
  • Children's Med. Ctr. Dallas
  • Texas Children's Hosp. CRS
  • UW School of Medicine - CHRMC
  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
  • San Juan City Hosp. PR NICHD CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00000789
Brief Title
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
Official Title
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome, Bristol-Myers Squibb

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Stavudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
230 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kline M
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Van Dyke R
Official's Role
Study Chair
Facility Information:
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Univ. of Connecticut Health Ctr., Dept. of Ped.
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Cook County Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cooper Univ. Hosp.
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
Country
United States
Facility Name
Children's Hospital at Albany Medical Center, Dept. of Peds.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx-Lebanon Hosp. IMPAACT CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore-Long Island Jewish Health System, Dept. of Peds.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp., Div. of Infectious Diseases
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Metropolitan Hosp. NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hosp. for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Jude/UTHSC CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Children's Med. Ctr. Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
8657531
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
9445494
Citation
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.
Results Reference
background
PubMed Identifier
21037891
Citation
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.
Results Reference
background

Learn more about this trial

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

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