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A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children Clinical research trials and A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children. A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children clinical trial. Subjects often receive the most expert healthcare possible for their A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children  A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 3 Months/17 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 819
Location and Contact Information:
Overall Study Official:
BakerC, Study Chair,
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
United States
UPR Children's Hosp / UPR School of Medicine
San Juan, , 009365067
Puerto Rico
Med Univ of South Carolina
Charleston, South Carolina, 29425
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Stanford Univ School of Medicine / Pediatrics
Stanford, California, 943054149
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Univ of Connecticut Health Ctr
Farmington, Connecticut, 06032
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, 452292899
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Bronx Lebanon Hosp Ctr / Pediatrics
Bronx, New York, 10457
United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
United States
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, 91105
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, 11203
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Children's Hosp of Seattle
Seattle, Washington, 98105
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Lincoln Hosp Ctr
Bronx, New York, 10451
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Kaiser Permanente / UCLA Med Ctr
Downey, California, 902422814
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Westchester Hosp
Valhalla, New York, 10595
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick, New Jersey, 08903
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
St Louis Univ School of Medicine
St. Louis, Missouri, 63104
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Additional Information:
Study ID Numbers: ACTG 152;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000637
Other Hiv Infections Studies:
1. Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection
2. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.
3. Distant Healing for HIV/AIDS
4. Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
5. Evaluation and Natural History of Children with Cancer and AIDS
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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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