Completed
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
230
Participants Needed
54
Research Sites
N/A
Total Duration
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
G
Glaxo Wellcome
Collaborating Sponsor
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
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Recommended:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Total: 54 locations
1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Status Unknown
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
Status Unknown
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90095
Status Unknown
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609
Status Unknown
5
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 92093
Status Unknown
6
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 94143
Status Unknown
7
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90502
Status Unknown
8
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80218
Status Unknown
9
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States, 06032
Status Unknown
10
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06504
Status Unknown
11
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States, 20010
Status Unknown
12
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20060
Status Unknown
13
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Status Unknown
14
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
Status Unknown
15
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States, 30306
Status Unknown
16
Cook County Hosp.
Chicago, Illinois, United States, 60612
Status Unknown
17
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States, 60612
Status Unknown
18
Chicago Children's CRS
Chicago, Illinois, United States, 60614
Status Unknown
19
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60637
Status Unknown
20
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
Status Unknown
21
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
Status Unknown
22
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Status Unknown
23
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
Status Unknown
24
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
Status Unknown
25
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01655
Status Unknown
26
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
Status Unknown
27
Cooper Univ. Hosp.
Camden, New Jersey, United States, 08103
Status Unknown
28
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States, 08903
Status Unknown
29
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
Status Unknown
30
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, United States, 12208
Status Unknown
31
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
Status Unknown
32
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States, 11021
Status Unknown
33
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
Status Unknown
34
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States, 10016
Status Unknown
35
Metropolitan Hosp. NICHD CRS
New York, New York, United States, 10029
Status Unknown
36
Columbia IMPAACT CRS
New York, New York, United States, 10032
Status Unknown
37
Incarnation Children's Ctr.
New York, New York, United States, 10032
Status Unknown
38
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Status Unknown
39
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Status Unknown
40
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794
Status Unknown
41
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
Status Unknown
42
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States, 10457
Status Unknown
43
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States
Status Unknown
44
DUMC Ped. CRS
Durham, North Carolina, United States, 27710
Status Unknown
45
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
46
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
Status Unknown
47
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 29425
Status Unknown
48
St. Jude/UTHSC CRS
Memphis, Tennessee, United States, 38105
Status Unknown
49
Children's Med. Ctr. Dallas
Dallas, Texas, United States, 75235
Status Unknown
50
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Status Unknown
51
UW School of Medicine - CHRMC
Seattle, Washington, United States, 98105
Status Unknown
52
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, Puerto Rico, 00956
Status Unknown
53
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Status Unknown
54
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00936
Status Unknown
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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