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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
Glaxo Wellcome Bristol-Myers Squibb |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000789 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Stavudine Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection |
| Estimated Enrollment: | 230 |
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| Ages Eligible for Study: | 3 Months to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Recommended:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham Schl of Med / Pediatrics | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| UCSF / Moffitt Hosp - Pediatric | |
| San Francisco, California, United States, 941430105 | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | |
| Los Angeles, California, United States, 905022004 | |
| Long Beach Memorial (Pediatric) | |
| Long Beach, California, United States, 90801 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Martin Luther King Jr Gen Hosp / UCLA Med Ctr | |
| Los Angeles, California, United States, 900593019 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 946091809 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| United States, Colorado | |
| Children's Hosp of Denver | |
| Denver, Colorado, United States, 802181088 | |
| United States, Connecticut | |
| Yale Univ Med School | |
| New Haven, Connecticut, United States, 06504 | |
| Univ of Connecticut / Farmington | |
| Farmington, Connecticut, United States, 06032 | |
| United States, District of Columbia | |
| Howard Univ Hosp | |
| Washington, District of Columbia, United States, 20060 | |
| Children's Hosp of Washington DC | |
| Washington, District of Columbia, United States, 200102916 | |
| United States, Florida | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| Univ of Florida Health Science Ctr / Pediatrics | |
| Jacksonville, Florida, United States, 32209 | |
| United States, Georgia | |
| Emory Univ Hosp / Pediatrics | |
| Atlanta, Georgia, United States, 30306 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Illinois College of Medicine / Pediatrics | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 606371470 | |
| United States, Louisiana | |
| Tulane Univ / Charity Hosp of New Orleans | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore / Univ Med Ctr | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Boston City Hosp / Pediatrics | |
| Boston, Massachusetts, United States, 02118 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ of Massachusetts Med School | |
| Worcester, Massachusetts, United States, 016550001 | |
| United States, Michigan | |
| Children's Hosp of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| UMDNJ - Robert Wood Johnson Med School / Pediatrics | |
| New Brunswick, New Jersey, United States, 089030019 | |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 071072198 | |
| Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 07103 | |
| Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| King's County Hosp Ctr / Pediatrics | |
| Brooklyn, New York, United States, 11203 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| SUNY - Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| Cornell Univ Med College | |
| New York, New York, United States, 10021 | |
| North Shore Univ Hosp | |
| Great Neck, New York, United States, 11021 | |
| Westchester Hosp | |
| Valhalla, New York, United States, 10595 | |
| Schneider Children's Hosp | |
| New Hyde Park, New York, United States, 11040 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Lincoln Hosp Ctr | |
| Bronx, New York, United States, 10451 | |
| Metropolitan Hosp Ctr | |
| New York, New York, United States, 10029 | |
| Children's Hosp at Albany Med Ctr | |
| Albany, New York, United States, 12208 | |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |
| Syracuse, New York, United States, 13210 | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10457 | |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| State Univ of New York at Stony Brook | |
| Stony Brook, New York, United States, 117948111 | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| Beth Israel Med Ctr / Pediatrics | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 277103499 | |
| Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati Children's Hosp / Univ Hosp | |
| Cincinnati, Ohio, United States, 452292899 | |
| Columbus Children's Hosp | |
| Columbus, Ohio, United States, 432052696 | |
| United States, Pennsylvania | |
| Children's Hosp of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 191044318 | |
| Saint Christopher's Hosp for Children | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, Rhode Island | |
| Rhode Island Hosp / Brown Univ | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 294253312 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hosp of Memphis | |
| Memphis, Tennessee, United States, 381052794 | |
| United States, Texas | |
| Children's Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Hermann Hosp / Univ Texas Health Science Ctr | |
| Houston, Texas, United States, 77030 | |
| Texas Children's Hosp / Baylor Univ | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Children's Hospital & Medical Center / Seattle ACTU | |
| Seattle, Washington, United States, 981050371 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Univ of Puerto Rico / Univ Children's Hosp AIDS | |
| San Juan, Puerto Rico, 009365067 | |
| Ramon Ruiz Arnau Univ Hosp / Pediatrics | |
| Bayamon, Puerto Rico, 00956 | |
| Study Chair: | Kline M | |
| Study Chair: | Van Dyke R |
More Information
| Study ID Numbers: | ACTG 240 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000789 History of Changes |
| Health Authority: | United States: Federal Government |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Stavudine |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |