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A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection Clinical research trials and A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection. A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection clinical trial. Human subjects often receive the most effective healthcare possible for their A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous 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'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection  A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome,Bristol-Myers Squibb
Synopsis: PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Details: At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined. Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/6 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis. Allowed: - Immunoglobulin. - Erythropoietin, G-CSF, and GM-CSF. - Corticosteroids. - Ethionamide or isoniazid for TB if no alternative is available. - Pyridoxine (up to 50 mg/day) as vitamin supplement. Patients must have: - Symptomatic HIV infection. - No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG). - Consent of parent or guardian. NOTE: - Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted. Prior Medication: Allowed: - Maternal immunomodulator or antiretroviral therapy (including during pregnancy). - Antiretroviral therapy prior to 2 months. - Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Current grade 3 or worse neuropathy / lower motor neuropathy. - Other grade 3 or worse clinical or laboratory toxicities. - Known intolerance to either AZT or d4T. Concurrent Medication: Excluded: - Chemotherapy for active malignancy. Patients with the following prior conditions are excluded: - History of grade 3 or worse neuropathy/lower motor neuropathy. Prior Medication: Excluded: - More than 6 weeks of prior antiretroviral or immunomodulator therapy. - Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.
Total Enrollment: 230
Location and Contact Information:
Overall Study Official:
KlineM, Study Chair,
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Lincoln Hosp Ctr
Bronx, New York, 10451
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
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
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Martin Luther King Jr Gen Hosp / UCLA Med Ctr
Los Angeles, California, 900593019
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, 08103
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, 452292899
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Additional Information:
Study ID Numbers: ACTG 240;
Study Start Date:
Record last reviewed: March 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000789
Other Hiv Infections Studies:
1. A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy
2. A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease
3. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy
4. KSHV Infection in Blood Donors from Texas
5. A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
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A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-deoxythymidine (Stavudine; d4T) in Children With HIV Infection
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