Back to resultsA Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zidovudine
Didanosine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Evaluation, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for > 72 hours. Systemic ketoconazole and fluconazole for acute therapy. Recommended: Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis. Patients must have the following: HIV infection. Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted. Prior Medication: Allowed: Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active malignancy. Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. History of uncontrolled seizure disorder. Grade 3 or higher peripheral neuropathy. Cardiomyopathy. Concurrent Medication: Excluded: Chemotherapy for malignancy. Oral acidifying agents. Acetaminophen, ibuprofen, or aspirin on a continual basis for > 72 hours. Ketoconazole or fluconazole for prophylaxis. Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for > 4 weeks. Patients with the following are excluded: Active malignancy. Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms. History of uncontrolled seizure disorder. Grade 3 or higher peripheral neuropathy. Prior Medication: Excluded: Steroids. Intravenous immunoglobulin. Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for > 6 weeks and within 7 days prior to study entry. Prior Treatment: Excluded: Red blood cell transfusion within four weeks prior to study entry. Ongoing drug or alcohol use.
Sites / Locations
- Univ of Alabama at Birmingham Schl of Med / Pediatrics
- Kaiser Permanente / UCLA Med Ctr
- UCSD Med Ctr / Pediatrics / Clinical Sciences
- Long Beach Memorial (Pediatric)
- Los Angeles County - USC Med Ctr
- Cedars Sinai / UCLA Med Ctr
- UCLA Med Ctr / Pediatric
- Harbor - UCLA Med Ctr / UCLA School of Medicine
- Children's Hosp of Oakland
- Huntington Memorial Hosp / Children's Hosp of Los Angeles
- Univ of California / San Diego Treatment Ctr
- UCSF / Moffitt Hosp - Pediatric
- Stanford Univ School of Medicine / Pediatrics
- Children's Hosp of Denver
- Univ of Connecticut Health Ctr
- Yale Univ Med School
- Georgetown Univ Med Ctr
- Children's Hosp of Washington DC
- Howard Univ Hosp
- Univ of Miami (Pediatric)
- Emory Univ Hosp / Pediatrics
- Cook County Hosp
- Univ of Illinois College of Medicine / Pediatrics
- Chicago Children's Memorial Hosp
- Univ of Chicago Children's Hosp
- Univ of Maryland at Baltimore / Univ Med Ctr
- Johns Hopkins Hosp - Pediatric
- Children's Hosp of Boston
- Boston City Hosp / Pediatrics
- Baystate Med Ctr of Springfield
- Univ of Massachusetts Med Ctr
- Children's Hosp of Michigan
- St Louis Univ School of Medicine
- UMDNJ - Robert Wood Johnson Med School / Pediatrics
- Robert Wood Johnson Med School / Hershey Med Ctr
- Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
- Children's Hosp at Albany Med Ctr
- Lincoln Hosp Ctr
- Bronx Lebanon Hosp Ctr / Pediatrics
- Bronx Lebanon Hosp Ctr
- Albert Einstein College of Medicine
- King's County Hosp Ctr / Pediatrics
- SUNY - Brooklyn
- SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
- Children's Hosp Pact Prog / Children's Hosp of Buffalo
- North Shore Univ Hosp
- Schneider Children's Hosp
- Beth Israel Med Ctr / Pediatrics
- Bellevue Hosp / New York Univ Med Ctr
- Cornell Univ Med College
- Saint Luke's - Roosevelt Hosp Ctr
- Metropolitan Hosp Ctr
- Mount Sinai Med Ctr / Pediatrics
- Columbia Presbyterian Med Ctr
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
- Harlem Hosp Ctr
- Univ of Rochester Medical Center
- State Univ of New York at Stony Brook
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
- Westchester Hosp
- Univ of North Carolina
- Duke Univ Med Ctr
- Cincinnati Children's Hosp / Univ Hosp
- Case Western Reserve Univ
- Columbus Children's Hosp
- Children's Hosp of Philadelphia
- Saint Christopher's Hosp for Children
- Hemophilia Ctr of Western PA / Univ of Pittsburgh
- Rhode Island Hosp / Brown Univ
- Med Univ of South Carolina
- Saint Jude Children's Research Hosp of Memphis
- Children's Med Ctr of Dallas
- Hermann Hosp / Univ Texas Health Science Ctr
- Texas Children's Hosp / Baylor Univ
- Children's Hosp of Seattle
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
- Univ of Puerto Rico / Univ Children's Hosp AIDS
- UPR Children's Hosp / UPR School of Medicine
- San Juan City Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000637
First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome
1. Study Identification
Unique Protocol Identification Number
NCT00000637
Brief Title
A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
Official Title
A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
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
September 1996 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome
4. Oversight
5. Study Description
Brief Summary
To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.
Detailed Description
AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.
Patients are placed by random selection into one of three groups to receive either AZT alone, ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating physician knows which group patient is in. If patients are receiving either AZT or ddI alone and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the alternative single drug is offered. If patients receiving both drugs develop drug toxicity (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted. Patients who reach crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently discontinued from study drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Drug Evaluation, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
819 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Didanosine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Acetaminophen, ibuprofen, or aspirin, but not on a continual basis for > 72 hours.
Systemic ketoconazole and fluconazole for acute therapy.
Recommended:
Prophylaxis for PCP. (Primary prophylaxis with TMP / SMX is encouraged.) IV pentamidine may be used in selected cases if not administered on a weekly basis.
Patients must have the following:
HIV infection.
Children randomized prior to their eighteenth birthday are eligible. Co-enrollment in either ACTG 179 or 189 is permitted.
Prior Medication:
Allowed:
Up to six weeks of antiretroviral or immunomodulator treatment excluding steroids and intravenous immunoglobulin.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Active malignancy.
Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
History of uncontrolled seizure disorder.
Grade 3 or higher peripheral neuropathy.
Cardiomyopathy.
Concurrent Medication:
Excluded:
Chemotherapy for malignancy.
Oral acidifying agents.
Acetaminophen, ibuprofen, or aspirin on a continual basis for > 72 hours.
Ketoconazole or fluconazole for prophylaxis.
Drugs with potential to cause peripheral neuropathy or pancreatitis should not be given daily for > 4 weeks.
Patients with the following are excluded:
Active malignancy.
Pancreatitis or history of pancreatitis within one year prior to study entry associated with compatible symptoms.
History of uncontrolled seizure disorder.
Grade 3 or higher peripheral neuropathy.
Prior Medication:
Excluded:
Steroids.
Intravenous immunoglobulin.
Antiretroviral drugs or specific immunomodulator treatment (excluding steroids and intravenous immunoglobulin) for > 6 weeks and within 7 days prior to study entry.
Prior Treatment:
Excluded:
Red blood cell transfusion within four weeks prior to study entry.
Ongoing drug or alcohol use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baker C
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Englund J
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham Schl of Med / Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Kaiser Permanente / UCLA Med Ctr
City
Downey
State/Province
California
ZIP/Postal Code
902422814
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Long Beach Memorial (Pediatric)
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900481804
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
Children's Hosp of Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
946091809
Country
United States
Facility Name
Huntington Memorial Hosp / Children's Hosp of Los Angeles
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Stanford Univ School of Medicine / Pediatrics
City
Stanford
State/Province
California
ZIP/Postal Code
943054149
Country
United States
Facility Name
Children's Hosp of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
802181088
Country
United States
Facility Name
Univ of Connecticut Health Ctr
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale Univ Med School
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200072197
Country
United States
Facility Name
Children's Hosp of Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102916
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ Hosp / Pediatrics
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 / Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Univ of Maryland at Baltimore / Univ Med Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Boston City Hosp / Pediatrics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med Ctr
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Children's Hosp of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St Louis Univ School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Med School / Pediatrics
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
Robert Wood Johnson Med School / Hershey Med Ctr
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071072198
Country
United States
Facility Name
Children's Hosp at Albany Med Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Lincoln Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr / Pediatrics
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
King's County Hosp Ctr / Pediatrics
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Children's Hosp Pact Prog / Children's Hosp of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
North Shore Univ Hosp
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell Univ Med College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Metropolitan Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
SUNY Health Sciences Ctr at Syracuse / Pediatrics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Westchester Hosp
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Cincinnati Children's Hosp / Univ Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452292899
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Saint Christopher's Hosp for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191341095
Country
United States
Facility Name
Hemophilia Ctr of Western PA / Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Rhode Island Hosp / Brown Univ
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Children's Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Hermann Hosp / Univ Texas Health Science Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hosp / Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hosp of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Ramon Ruiz Arnau Univ Hosp / Pediatrics
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Univ of Puerto Rico / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
UPR Children's Hosp / UPR School of Medicine
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
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10469815
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
11362451
Citation
Glick ME. CTG studies yield results. AIDS Clinical Trials Group. NIAID AIDS Agenda. 1995 Spring:8-9.
Results Reference
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PubMed Identifier
7657952
Citation
Rogers MF, Mofenson LM, Moseley RR. Reducing the risk of perinatal HIV transmission through zidovudine therapy: treatment recommendations and implications. J Am Med Womens Assoc (1972). 1995 May-Aug;50(3-4):78-82, 93.
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PubMed Identifier
7622878
Citation
Nielsen K, Wei LS, Sim MS, Deveikis A, Keller M, Stiehm ER, Frenkel LM, Bryson YJ. Correlation of clinical progression in human immunodeficiency virus-infected children with in vitro zidovudine resistance measured by a direct quantitative peripheral blood lymphocyte assay. J Infect Dis. 1995 Aug;172(2):359-64. doi: 10.1093/infdis/172.2.359.
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PubMed Identifier
9508151
Citation
Palumbo PE, Raskino C, Fiscus S, Pahwa S, Fowler MG, Spector SA, Englund JA, Baker CJ. Predictive value of quantitative plasma HIV RNA and CD4+ lymphocyte count in HIV-infected infants and children. JAMA. 1998 Mar 11;279(10):756-61. doi: 10.1001/jama.279.10.756.
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PubMed Identifier
7965424
Citation
McKinney RE Jr, Wilfert C. Growth as a prognostic indicator in children with human immunodeficiency virus infection treated with zidovudine. AIDS Clinical Trials Group Protocol 043 Study Group. J Pediatr. 1994 Nov;125(5 Pt 1):728-33. doi: 10.1016/s0022-3476(94)70065-6.
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PubMed Identifier
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Citation
James JS. AZT, ddI, and ddC combinations at FDA advisory hearing. Food and Drug Administration. AIDS Treat News. 1996 Apr 5;(no 244):6.
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Englund JA, Baker CJ, McKinney RE, Raskino CL, Fowler MG, Lifschitz MC. Results of ACTG 152, a randomized comparative trial of zidovudine (ZDV), didanosine (ddI), and ZDV/ddI combination therapy in symptomatic HIV-infected children. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1996 Sep 15-18:213 (abstract no I150)
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Citation
Englund JA, Baker CJ, Raskino C, McKinney RE, Petrie B, Fowler MG, Pearson D, Gershon A, McSherry GD, Abrams EJ, Schliozberg J, Sullivan JL. Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children. AIDS Clinical Trials Group (ACTG) Study 152 Team. N Engl J Med. 1997 Jun 12;336(24):1704-12. doi: 10.1056/NEJM199706123362403.
Results Reference
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PubMed Identifier
12616665
Citation
Capparelli EV, Englund JA, Connor JD, Spector SA, McKinney RE, Palumbo P, Baker CJ. Population pharmacokinetics and pharmacodynamics of zidovudine in HIV-infected infants and children. J Clin Pharmacol. 2003 Feb;43(2):133-40. doi: 10.1177/0091270002239821.
Results Reference
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PubMed Identifier
14688560
Citation
Chantry CJ, Byrd RS, Englund JA, Baker CJ, McKinney RE Jr; Pediatric AIDS Clinical Trials Group Protocol 152 Study Team. Growth, survival and viral load in symptomatic childhood human immunodeficiency virus infection. Pediatr Infect Dis J. 2003 Dec;22(12):1033-9. doi: 10.1097/01.inf.0000100575.64298.bc.
Results Reference
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Learn more about this trial
A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
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