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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: | NCT00000625 |
Purpose
To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3 |
| Estimated Enrollment: | 2100 |
Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm.
PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
PER AMENDMENT 4/5/95:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Current alcohol abuse.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Univ of Washington / Children's Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Huntington Memorial Hosp / Children's Hosp of Los Angeles | |
| Pasadena, California, United States, 91105 | |
| Children's Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| UCSD / Children's Hosp Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
| San Jose, California, United States, 951282699 | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| United States, Colorado | |
| Univ Hosp / Univ of Colorado Health Sci Ctr | |
| Denver, Colorado, United States, 80262 | |
| Mountain States Reg Hemo Ctr / Univ of Colorado | |
| Denver, Colorado, United States, 80262 | |
| Mountain States Hemo Ctr / Univ of Utah | |
| Denver, Colorado, United States, 80262 | |
| Saint Joseph's Hosp & Med Ctr / Mtn States Reg Hemo Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Connecticut Children's Med Ctr | |
| Farmington, Connecticut, United States, 060303805 | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Howard Univ | |
| Washington, District of Columbia, United States, 20059 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| HIV Ctr - District of Columbia Gen Hosp | |
| Washington, District of Columbia, United States, 200072197 | |
| George Washington Univ / Hershey Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Georgia | |
| Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr | |
| Atlanta, Georgia, United States, 303652225 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Children's Mem Hosp Family Cln / Northwestern Univ Med Schl | |
| Chicago, Illinois, United States, 60611 | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| Indiana Univ / Riley Hosp for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Great Plains - Hemophilia / Univ of Iowa Hosp & Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| Univ of Iowa Hosp and Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Univ of Louisville / East Tennesee Comprehensive Hem Ctr | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Charity Hosp / Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Med Ctr Hosp | |
| New Orleans, Louisiana, United States, 70112 | |
| Tulane Univ / Charity Hosp of New Orleans | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| State of MD Div of Corrections / Johns Hopkins Univ Hosp | |
| Baltimore, Maryland, United States, 212052196 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Boston City Hosp / Pediatrics | |
| Boston, Massachusetts, United States, 02118 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | |
| Worcester, Massachusetts, United States, 01605 | |
| Rhode Island Hemophilia Ctr / Med Ctr of Cntrl MA | |
| Worcester, Massachusetts, United States, 01605 | |
| Brigham and Women's Hosp | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Children's Hosp of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| Michigan State Univ Hemophilia Comprehensive Care Clinic | |
| Lansing, Michigan, United States, 48912 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| St Paul Ramsey Med Ctr | |
| St Paul, Minnesota, United States, 55101 | |
| United States, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | |
| St Louis, Missouri, United States, 63112 | |
| United States, Nebraska | |
| Nebraska Regional Hemophilia Ctr / Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| St Louis Univ Med Ctr / Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New Hampshire | |
| Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| Robert Wood Johnson Med School / Hershey Med Ctr | |
| New Brunswick, New Jersey, United States, 08903 | |
| UMDNJ - New Jersey Med School | |
| Newark, New Jersey, United States, 07107 | |
| United States, New York | |
| Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Samaritan Village Inc / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Nassau County Med Ctr | |
| East Meadow, New York, United States, 11554 | |
| SUNY / State Univ of New York | |
| Syracuse, New York, United States, 13210 | |
| SUNY - Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| 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 | |
| Saint Clare's Hosp and Health Ctr | |
| New York, New York, United States, 10019 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Mount Sinai Med Ctr / Hemophilia Treatment Ctr | |
| New York, New York, United States, 10029 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Puerto Genetic Disease Clinic | |
| New York, New York, United States, 10029 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 112032098 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| North Shore Univ Hosp | |
| Manhasset, New York, United States, 11030 | |
| North Central Bronx Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Wake Med Ctr / Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28203 | |
| Wake County Dept of Health | |
| Raleigh, North Carolina, United States, 27610 | |
| Moses H Cone Memorial Hosp | |
| Greensboro, North Carolina, United States, 27401 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Glaxo Wellcome Inc | |
| Research Triangle Park, North Carolina, United States, 27709 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| Med College of Ohio | |
| Toledo, Ohio, United States, 43699 | |
| Northwest Ohio Hemo Treatment Ctr / Great Lakes Hemo Fdn | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oregon | |
| Oregon Health Sciences Univ / Children's Hosp of Los Angeles | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Milton S Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| Hemophilia Ctr of Western PA / Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Univ of Pittsburgh Med School / Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 170330850 | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Med Univ of South Carolina / UNC | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Texas | |
| Univ Texas Health Science Ctr / Univ Texas Med School | |
| Houston, Texas, United States, 77030 | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224304 | |
| United States, Wisconsin | |
| Great Lakes Hemophilia Foundation | |
| Wauwatosa, Wisconsin, United States, 532130127 | |
| Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp | |
| Green Bay, Wisconsin, United States, 54301 | |
| Comp Hemo Ctr of Ctrl & N Illinois / Great Lakes Hemo Fdn | |
| Wauwatosa, Wisconsin, United States, 532130127 | |
| Youngstown Hemophilia Ctr / Great Lakes Hemophilia Fdn | |
| Wauwatosa, Wisconsin, United States, 53213 | |
| Puerto Rico | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Katzenstein D | |
| Study Chair: | Hammer S |
More Information
| Study ID Numbers: | ACTG 175 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000625 History of Changes |
| Health Authority: | United States: Federal Government |
|
Zalcitabine Didanosine Drug Therapy, Combination |
AIDS-Related Complex Antiviral Agents Zidovudine |
|
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 Zalcitabine Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |