Trial of Stavudine (d4T) Plus Didanosine (ddI) in Children on Long-Term Stavudine Monotherapy, and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy: A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
198
Participants Needed
35
Research Sites
N/A
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
Trial Site Locations
How is the study designed?
Frequently Asked Questions
Research Publications
AI-Summary
What this Trial Is About
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden.
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
CONDITIONS
Official Title
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
Who Can Participate
Age: 6Months - 10Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients must:
Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment.
Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody
Have parent or legal guardian willing to sign a consent.
Prior Medication: Required:
On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Intractable diarrhea or vomiting.
Current clinical or laboratory Grade 3 or worse toxicities.
Concurrent Medication:
Excluded:
Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219.
Chemotherapy for active malignancy.
Patients with any of the following prior conditions are excluded:
Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment.
Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
Subjects who have had chemotherapy for active malignancy.
Prior Medication:
Excluded:
Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
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: 35 locations
1
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90502
Status Unknown
2
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Status Unknown
3
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States, 06032
Status Unknown
4
Connecticut Children's Med. Ctr.
Hartford, Connecticut, United States
Status Unknown
5
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States, 20010
Status Unknown
6
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20060
Status Unknown
7
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Status Unknown
8
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
Status Unknown
9
Cook County Hosp.
Chicago, Illinois, United States, 60612
Status Unknown
10
Chicago Children's CRS
Chicago, Illinois, United States, 60614
Status Unknown
11
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60637
Status Unknown
12
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
Status Unknown
13
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States, 21201
Status Unknown
14
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Status Unknown
15
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
Status Unknown
16
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States, 08903
Status Unknown
17
NJ Med. School CRS
Newark, New Jersey, United States
Status Unknown
18
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
Status Unknown
19
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States, 11021
Status Unknown
20
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
Status Unknown
21
Metropolitan Hosp. NICHD CRS
New York, New York, United States, 10029
Status Unknown
22
Columbia IMPAACT CRS
New York, New York, United States, 10032
Status Unknown
23
Incarnation Children's Ctr.
New York, New York, United States, 10032
Status Unknown
24
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Status Unknown
25
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
Status Unknown
26
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
Status Unknown
27
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States, 10457
Status Unknown
28
DUMC Ped. CRS
Durham, North Carolina, United States, 27710
Status Unknown
29
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
Status Unknown
30
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 29425
Status Unknown
31
Children's Med. Ctr. Dallas
Dallas, Texas, United States, 75235
Status Unknown
32
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Status Unknown
33
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, Puerto Rico, 00956
Status Unknown
34
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Status Unknown
35
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico, 00936
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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Combination therapy with stavudine (d4T) plus didanosine (ddI) in children with human immunodeficiency virus infection. The Pediatric AIDS Clinical Trials Group 327 Team.