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| Sponsor: | Pharmacia and Upjohn |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002123 |
Purpose
To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Delavirdine mesylate Drug: Didanosine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 |
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Required:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 352942041 | |
| United States, California | |
| ViRx Inc | |
| San Francisco, California, United States, 94103 | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 94063 | |
| UCD Med Ctr / AIDS and Related Disorders Clinic | |
| Sacramento, California, United States, 95817 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Los Angeles County / Health Research Assoc / Drew Med Ctr | |
| Los Angeles, California, United States, 90059 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90509 | |
| Shared Med Research Foundation | |
| Tarzana, California, United States, 91356 | |
| UCSD / Ctr for Special Immunology | |
| San Diego, California, United States, 92103 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Saint Francis Mem Hosp | |
| San Francisco, California, United States, 94109 | |
| California Med Research Group | |
| Fresno, California, United States, 93726 | |
| St Lukes Medical Group | |
| San Diego, California, United States, 92101 | |
| CARE Ctr / UCLA Med Ctr | |
| Los Angeles, California, United States, 90095 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| United States, Colorado | |
| Univ Hosp / Univ of Colorado Health Sci Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Caremark Inc | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Infectious Disease Rsch Consortium of GA / SE Clin Resources | |
| Atlanta, Georgia, United States, 30345 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Infectious Disease Research Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Univ of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine / Univ Hosp | |
| Kansas City, Kansas, United States, 661607354 | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| Univ of Kentucky Med Ctr / Chandler Med Ctr | |
| Lexington, Kentucky, United States, 405360084 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Maine | |
| AIDS Consultation Service / Maine Med Ctr | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Massachusetts Gen Hosp | |
| Boston, Massachusetts, United States, 02114 | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| New England Deaconess Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| Boston City Hosp / FGH-1 | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Women's Hosp | |
| Boston, Massachusetts, United States, 02115 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Michigan | |
| Harper Hosp | |
| Detroit, Michigan, United States, 48201 | |
| Univ of Michigan Hospitals and Health Ctrs | |
| Ann Arbor, Michigan, United States, 481090378 | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| St Paul Ramsey Med Ctr / HIV Program Office | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, Missouri | |
| Washington Univ | |
| St. Louis, Missouri, United States, 63110 | |
| Univ of Missouri at Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr / HIV Clinic | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New Jersey | |
| Jersey Shore Med Ctr | |
| Neptune, New Jersey, United States, 07753 | |
| United States, New York | |
| New York Med College / Westchester County Med Ctr | |
| Valhalla, New York, United States, 10595 | |
| Community Research Initiative on AIDS | |
| New York, New York, United States, 10001 | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| Albany Med College | |
| Albany, New York, United States, 122083479 | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| Community Health Network | |
| Rochester, New York, United States, 14620 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| New York Hosp - Cornell Med Ctr | |
| New York, New York, United States, 10021 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28204 | |
| Univ of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Univ of Cincinnati / Holmes Hosp | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania / HIV Clinic | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pennsylvania State Univ / Hershey Med Ctr | |
| Hershey, Pennsylvania, United States, 17033 | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Children's Hosp of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Oncology and Hematology Association | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| Univ of Pittsburgh Med School | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Rhode Island | |
| Mem Hosp of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, South Carolina | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Vanderbilt Univ | |
| Nashville, Tennessee, United States, 37212 | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Park Plaza Hosp | |
| Houston, Texas, United States, 77004 | |
| Houston Veterans Administration Med Ctr | |
| Houston, Texas, United States, 77030 | |
| Univ TX Health Science Ctr | |
| Houston, Texas, United States, 77030 | |
| Dallas Veterans Administration Med Ctr | |
| Dallas, Texas, United States, 75216 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| United States, Vermont | |
| Med Ctr of Vermont Hosp | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| Richmond AIDS Consortium | |
| Richmond, Virginia, United States, 23219 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Univ of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Puerto Rico | |
| UPR School of Medicine | |
| San Juan, Puerto Rico, 00936 | |
More Information
| Study ID Numbers: | 228A, M/3331/0017 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002123 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action 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 |