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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: | NCT00001029 |
Purpose
To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3.
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy |
| Estimated Enrollment: | 654 |
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly with ddI will start with AZT, while the other half will start with ddI. Treatment continues until death or termination of the study. Patients are followed every 4 weeks. The study will include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic assessments will be made.
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:
Patients must have:
Prior Medication: Required:
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:
Contacts and Locations
Hide Study Locations| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| 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 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Whitman - Walker Clinic / Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 200072197 | |
| HIV Ctr - District of Columbia Gen Hosp | |
| Washington, District of Columbia, United States, 200072197 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| 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 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Hennepin County Med Clinic | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | |
| St Louis, Missouri, United States, 63112 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| 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 | |
| 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 | |
| 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 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| North Shore Univ Hosp | |
| Manhasset, New York, United States, 11030 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| 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 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 112032098 | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| North Central Bronx Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Comprehensive Health Care Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Med College of Ohio | |
| Toledo, Ohio, United States, 43699 | |
| Columbus Children's Hosp | |
| Columbus, Ohio, United States, 432052696 | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| 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 | |
| Puerto Rico | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | WK Henry | |
| Study Chair: | JO Kahn | |
| Study Chair: | HH Balfour |
More Information
| Study ID Numbers: | ACTG 193 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001029 History of Changes |
| Health Authority: | United States: Federal Government |
|
Zalcitabine Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome 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 |