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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: | NCT00000803 |
Purpose
To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.
U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Delavirdine mesylate Drug: Zidovudine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy |
| Estimated Enrollment: | 471 |
U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed for cutaneous Kaposi's sarcoma:
Patients must have:
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:
Excluded within the past 30 days:
Active drug or alcohol use.
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 | |
| VA Hosp at San Diego / Pediatrics | |
| San Diego, California, United States, 92161 | |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| Summitt Med Ctr / San Francisco Gen Hosp | |
| Oakland, California, United States, 94609 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr | |
| Los Angeles, California, United States, 900334508 | |
| United States, Colorado | |
| Denver Dept of Health and Hosps | |
| Denver, Colorado, United States, 80262 | |
| Kaiser Permanente Franklin Med Ctr | |
| Denver, Colorado, United States, 80262 | |
| Rose Med Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, District of Columbia | |
| Howard Univ | |
| Washington, District of Columbia, United States, 20059 | |
| 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, Hawaii | |
| Queens Med Ctr | |
| Honolulu, Hawaii, United States, 96816 | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| 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 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | |
| St Louis, Missouri, United States, 63112 | |
| United States, New York | |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| SUNY / State Univ of New York | |
| Syracuse, New York, United States, 13210 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| 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 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| North Central Bronx Hosp / 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 | |
| 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 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 112032098 | |
| North Shore Univ Hosp | |
| Manhasset, New York, United States, 11030 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Comprehensive Health Care Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 100323784 | |
| Adirondack Med Ctr at Saranac Lake | |
| Albany, New York, United States, 122083479 | |
| Mid - Hudson Care Ctr | |
| Albany, New York, United States, 122083479 | |
| Albany Med College / Division of HIV Medicine A158 | |
| Albany, New York, United States, 122083479 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| 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 | |
| United States, Pennsylvania | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224304 | |
| United States, Wisconsin | |
| 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: | Friedland G | |
| Study Chair: | Fischl MA | |
| Study Chair: | Pollard R |
More Information
| Study ID Numbers: | ACTG 261 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000803 History of Changes |
| Health Authority: | United States: Federal Government |
|
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents Zidovudine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Delavirdine 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 |