Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare.
Melanie Perrier, Tobias Schwarz, Olga Gonzalez...
https://pubmed.ncbi.nlm.nih.gov/21037891Completed
Phase 2
Age: 3Months - 18Years
All Genders
ID00000963
A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
300
Participants Needed
52
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 evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT. The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
CONDITIONS
Official Title
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
Who Can Participate
Age: 3Months - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
- Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
- Immunoglobulin.
- Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.
Concurrent Treatment:
Allowed:
- Blood transfusions.
Prior Medication:
Allowed:
- Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.
- Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.
- Patient or guardian available to give written informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded.
- Hypersensitivity to didanosine (ddI).
- Symptomatic cardiomyopathy.
- Seizures that are not well controlled by ongoing anticonvulsant therapy.
- Symptomatic pancreatitis.
- Grade 1 or higher peripheral neuropathy.
- Active malignancy requiring chemotherapy.
Concurrent Medication:
Excluded:
- Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.
Avoid:
- Drugs with potential to cause peripheral neuropathy or pancreatitis.
Patients with the following are excluded:
- Active malignancy requiring concomitant chemotherapy.
Prior Medication:
Excluded:
- Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.
- Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
- Any other experimental therapy within 1 week of entry.
- Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of 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: 52 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
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
Status Unknown
8
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States, 06032
Status Unknown
9
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States, 06504
Status Unknown
10
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States, 20010
Status Unknown
11
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20060
Status Unknown
12
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
Status Unknown
13
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States, 30306
Status Unknown
14
Cook County Hosp.
Chicago, Illinois, United States, 60612
Status Unknown
15
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States, 60612
Status Unknown
16
Chicago Children's CRS
Chicago, Illinois, United States, 60614
Status Unknown
17
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60637
Status Unknown
18
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
Status Unknown
19
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Status Unknown
20
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
Status Unknown
21
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 21287
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
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
Status Unknown
28
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States
Status Unknown
29
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, United States, 12208
Status Unknown
30
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
Status Unknown
31
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States, 11021
Status Unknown
32
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
Status Unknown
33
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States, 10016
Status Unknown
34
Metropolitan Hosp. NICHD CRS
New York, New York, United States, 10029
Status Unknown
35
Columbia IMPAACT CRS
New York, New York, United States, 10032
Status Unknown
36
Incarnation Children's Ctr.
New York, New York, United States, 10032
Status Unknown
37
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Status Unknown
38
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Status Unknown
39
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794
Status Unknown
40
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
Status Unknown
41
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States, 10457
Status Unknown
42
DUMC Ped. CRS
Durham, North Carolina, United States, 27710
Status Unknown
43
Case CRS
Cleveland, Ohio, United States, 44106
Status Unknown
44
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
45
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
Status Unknown
46
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 29425
Status Unknown
47
Children's Med. Ctr. Dallas
Dallas, Texas, United States, 75235
Status Unknown
48
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Status Unknown
49
UW School of Medicine - CHRMC
Seattle, Washington, United States, 98105
Status Unknown
50
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, Puerto Rico, 00956
Status Unknown
51
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Status Unknown
52
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here