Completed
Phase 2
Age: 3Months - 15Years
All Genders
ID00001066
A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2011-03-02
740
Participants Needed
91
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens. Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
CONDITIONS
Official Title
A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children
Who Can Participate
Age: 3Months - 15Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
- IVIG.
- Prophylaxis for opportunistic infection.
- EPO.
- G-CSF or GM-CSF.
Patients must have:
- Symptomatic HIV infection.
- Less than 56 days of prior antiretroviral therapy.
- Consent of parent or guardian.
NOTE:
- Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.
Prior Medication:
Allowed:
- Up to 56 days of prior antiretroviral therapy.
- Prior immunomodulator therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Malignancy.
- Hypersensitivity to a nucleoside analog.
- Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.
PER AMENDMENT 4/29/96:
- Active opportunistic infection and/or serious bacterial infection at the time of entry.
Concurrent Medication:
Excluded:
- Any other anti-HIV therapy.
- Megestrol acetate ( Megace ).
- Probenecid.
- IV pentamidine.
- Human growth hormone ( hGH ).
- Systemic corticosteroids for more than 2 weeks.
Prior Medication:
Excluded:
- Investigational drug therapy within 14 days prior to study entry.
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
Trial Site Locations
Total: 91 locations
1
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States, 35294
Status Unknown
2
Arkansas Children's Hosp
Little Rock, Arkansas, United States, 72202
Status Unknown
3
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Status Unknown
4
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Status Unknown
5
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Status Unknown
6
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
7
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Status Unknown
8
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Status Unknown
9
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Status Unknown
10
Univ of California / Davis
Sacramento, California, United States, 958172208
Status Unknown
11
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Status Unknown
12
Stanford Univ School of Medicine
Stanford, California, United States, 943054149
Status Unknown
13
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
Status Unknown
14
Univ of Connecticut / Farmington
Farmington, Connecticut, United States, 06032
Status Unknown
15
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Status Unknown
16
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States, 200102916
Status Unknown
17
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
18
Children's Diagnostic and Treatment Ctr of South Florida
Fort Lauderdale, Florida, United States, 33301
Status Unknown
19
Univ of Florida
Gainesville, Florida, United States, 32610
Status Unknown
20
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
21
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
22
Arnold Palmer Hosp for Children & Women
Orlando, Florida, United States, 32806
Status Unknown
23
All Children's Hosp
St. Petersburg, Florida, United States, 33701
Status Unknown
24
Univ of South Florida
Tampa, Florida, United States, 33606
Status Unknown
25
Saint Joseph's Hosp
Tampa, Florida, United States, 33614
Status Unknown
26
HRS Palm Beach County Public Health Unit
West Palm Beach, Florida, United States, 33407
Status Unknown
27
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
Status Unknown
28
Med College of Georgia
Augusta, Georgia, United States, 30912
Status Unknown
29
Mem Children's Hosp
Savannah, Georgia, United States, 31404
Status Unknown
30
Mount Sinai Hosp Med Ctr
Chicago, Illinois, United States, 60608
Status Unknown
31
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
32
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Status Unknown
33
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
34
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
Status Unknown
35
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
36
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Status Unknown
37
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
Status Unknown
38
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
39
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Status Unknown
40
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
41
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
Status Unknown
42
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
Status Unknown
43
Univ of Minnesota Med School
Minneapolis, Minnesota, United States, 55455
Status Unknown
44
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 392165405
Status Unknown
45
St Louis Children's Hosp
St Louis, Missouri, United States, 63110
Status Unknown
46
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Status Unknown
47
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
48
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
Status Unknown
49
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
Status Unknown
50
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Status Unknown
51
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States, 11203
Status Unknown
52
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
Status Unknown
53
Children's Hosp of Buffalo
Buffalo, New York, United States, 14222
Status Unknown
54
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
55
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Status Unknown
56
Beth Israel Med Ctr / Pediatrics
New York, New York, United States, 10003
Status Unknown
57
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
58
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Status Unknown
59
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Status Unknown
60
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
Status Unknown
61
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
62
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
63
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
64
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Status Unknown
65
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Status Unknown
66
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10457
Status Unknown
67
Westchester Hosp
Valhalla, New York, United States, 10595
Status Unknown
68
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Status Unknown
69
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
70
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, United States, 452292899
Status Unknown
71
Case Western Reserve Univ - Pediatric
Cleveland, Ohio, United States, 44106
Status Unknown
72
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
Status Unknown
73
Children's Med Ctr
Dayton, Ohio, United States, 454041518
Status Unknown
74
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
Status Unknown
75
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
Status Unknown
76
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, United States, 02903
Status Unknown
77
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
78
Univ of South Carolina School of Med
Columbia, South Carolina, United States, 29203
Status Unknown
79
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Status Unknown
80
Children's Med Ctr of Dallas
Dallas, Texas, United States, 75235
Status Unknown
81
Cook - Fort Worth Children's Med Ctr
Fort Worth, Texas, United States, 76104
Status Unknown
82
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, United States, 77030
Status Unknown
83
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
Status Unknown
84
Univ of Texas Health Science Ctr
San Antonio, Texas, United States, 78240
Status Unknown
85
Senetara Norfolk Gen Hosp
Norfolk, Virginia, United States, 23507
Status Unknown
86
Virginia Commonwealth Univ
Richmond, Virginia, United States, 232980413
Status Unknown
87
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
88
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, Puerto Rico, 00956
Status Unknown
89
Mayaguez Med Ctr
Mayagüez, Puerto Rico, 00680
Status Unknown
90
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Status Unknown
91
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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