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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001066 |
Purpose
To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens.
Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lamivudine Drug: Zidovudine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children |
| Estimated Enrollment: | 740 |
Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.
Eligibility| Ages Eligible for Study: | 3 Months to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
PER AMENDMENT 4/29/96:
Concurrent Medication:
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, Arkansas | |
| Arkansas Children's Hosp | |
| Little Rock, Arkansas, United States, 72202 | |
| 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 | |
| Univ of California / Davis | |
| Sacramento, California, United States, 958172208 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Children's Hosp of Los Angeles/UCLA Med Ctr | |
| Los Angeles, California, United States, 900276016 | |
| Long Beach Memorial (Pediatric) | |
| Long Beach, California, United States, 90801 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Children's Hosp of Oakland | |
| Oakland, California, United States, 946091809 | |
| Stanford Univ School of Medicine | |
| Stanford, California, United States, 943054149 | |
| 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 Florida | |
| Gainesville, Florida, United States, 32610 | |
| Univ of Florida Health Science Ctr / Pediatrics | |
| Jacksonville, Florida, United States, 32209 | |
| All Children's Hosp | |
| St Petersburg, Florida, United States, 33701 | |
| Children's Diagnostic and Treatment Ctr of South Florida | |
| Fort Lauderdale, Florida, United States, 33301 | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| Univ of South Florida | |
| Tampa, Florida, United States, 33606 | |
| Arnold Palmer Hosp for Children & Women | |
| Orlando, Florida, United States, 32806 | |
| HRS Palm Beach County Public Health Unit | |
| West Palm Beach, Florida, United States, 33407 | |
| Saint Joseph's Hosp | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Emory Univ Hosp / Pediatrics | |
| Atlanta, Georgia, United States, 30306 | |
| Mem Children's Hosp | |
| Savannah, Georgia, United States, 31404 | |
| Med College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| 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 | |
| Mount Sinai Hosp Med Ctr | |
| Chicago, Illinois, United States, 60608 | |
| 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 | |
| Johns Hopkins Hosp - Pediatric | |
| Baltimore, Maryland, United States, 212874933 | |
| 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, Minnesota | |
| Univ of Minnesota Med School | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| Univ of Mississippi Med Ctr | |
| Jackson, Mississippi, United States, 392165405 | |
| United States, Missouri | |
| St Louis Children's Hosp | |
| St Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| 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 | |
| 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 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| 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 | |
| SUNY - Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| 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 | |
| State Univ of New York at Stony Brook | |
| Stony Brook, New York, United States, 117948111 | |
| Beth Israel Med Ctr / Pediatrics | |
| New York, New York, United States, 10003 | |
| Children's Hosp of Buffalo | |
| Buffalo, New York, United States, 14222 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| 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 | |
| Case Western Reserve Univ - Pediatric | |
| Cleveland, Ohio, United States, 44106 | |
| Cincinnati Children's Hosp / Univ Hosp | |
| Cincinnati, Ohio, United States, 452292899 | |
| Columbus Children's Hosp | |
| Columbus, Ohio, United States, 432052696 | |
| Children's Med Ctr | |
| Dayton, Ohio, United States, 454041518 | |
| 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 | |
| Univ of South Carolina School of Med | |
| Columbia, South Carolina, United States, 29203 | |
| 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 | |
| Cook - Fort Worth Children's Med Ctr | |
| Fort Worth, Texas, United States, 76104 | |
| Univ of Texas Health Science Ctr | |
| San Antonio, Texas, United States, 78240 | |
| United States, Virginia | |
| Senetara Norfolk Gen Hosp | |
| Norfolk, Virginia, United States, 23507 | |
| Virginia Commonwealth Univ | |
| Richmond, Virginia, United States, 232980413 | |
| 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 | |
| Mayaguez Med Ctr | |
| Mayaguez, Puerto Rico, 00680 | |
| Study Chair: | McKinney RE | |
| Study Chair: | Johnson GM |
More Information
| Study ID Numbers: | ACTG 300 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001066 History of Changes |
| Health Authority: | United States: Federal Government |
|
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Zidovudine Lamivudine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine 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 Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |