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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000814 |
Purpose
To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection.
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nevirapine Drug: Zidovudine Drug: Didanosine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease |
| Estimated Enrollment: | 390 |
The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks.
AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.
Eligibility| Ages Eligible for Study: | 6 Months to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded (unless exemption made by study chair):
Patients with the following prior conditions are excluded:
Prior Treatment:
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 | |
| Cedars Sinai / UCLA Med Ctr | |
| Los Angeles, California, United States, 900481804 | |
| 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 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 200072197 | |
| 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 | |
| Johns Hopkins Hosp - Pediatric | |
| Baltimore, Maryland, United States, 212874933 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| 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 | |
| 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 | |
| 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 | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| Metropolitan Hosp Ctr | |
| New York, New York, United States, 10029 | |
| Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10461 | |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |
| Syracuse, New York, United States, 13210 | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10457 | |
| Mount Sinai Med Ctr / Hemophilia Treatment Ctr | |
| New York, New York, United States, 10029 | |
| 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 | |
| Beth Israel Med Ctr / Pediatrics | |
| New York, New York, United States, 10003 | |
| Children's Hosp at Albany Med Ctr | |
| Albany, New York, United States, 12208 | |
| 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 | |
| Columbus Children's Hosp | |
| Columbus, Ohio, United States, 432052696 | |
| West Central Ohio Hemophilia Ctr / Children's Med Ctr | |
| Dayton, Ohio, United States, 454041815 | |
| United States, Pennsylvania | |
| Children's Hosp of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 191044318 | |
| Univ of Pittsburgh Med School / Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| Milton S Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| 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, Texas | |
| Children's Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Texas Children's Hosp / Baylor Univ | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Children's Hosp of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| 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: | Burchett S | |
| Study Chair: | Luzuriaga K |
More Information
| Study ID Numbers: | ACTG 245 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000814 History of Changes |
| Health Authority: | United States: Federal Government |
|
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Zidovudine Nevirapine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases 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 Nevirapine Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
