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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00002307 |
Purpose
To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Stavudine Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3 |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Required:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Univ of Arizona / Health Science Ctr | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Combat Group | |
| Los Angeles, California, United States, 90028 | |
| Cedars Sinai Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| Children's Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| UCD Med Ctr / AIDS and Related Disorders Clinic | |
| Sacramento, California, United States, 95817 | |
| Children's Hosp of San Francisco | |
| San Francisco, California, United States, 94118 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Whitman - Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of Miami | |
| Miami, Florida, United States, 331016960 | |
| Community Research Initiative of South Florida | |
| Coral Gables, Florida, United States, 33146 | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Dr Steven Marlowe | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Infectious Diseases Research Clinic / Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| 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, 672143124 | |
| United States, Maryland | |
| Chase Braxton Health Service | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| New England Deaconess Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr / HIV Clinic | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New Mexico | |
| Univ of New Mexico School of Medicine | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Bronx Veterans Affairs Med Ctr | |
| Bronx, New York, United States, 10468 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10019 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Cornell Univ Med College | |
| New York, New York, United States, 10021 | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Nalle Clinic | |
| Charlotte, North Carolina, United States, 28207 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania / HIV Clinic | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Montefiore Hosp | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Med Univ of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77006 | |
| Dr Edward Stool | |
| Houston, Texas, United States, 77004 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 782847881 | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 75235 | |
| United States, Utah | |
| Univ of Utah School of Medicine | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Wisconsin | |
| Milwaukee County Med Complex | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Puerto Rico | |
| UPR School of Medicine / San Juan Veterans Adm Med Ctr | |
| San Juan, Puerto Rico, 009275800 | |
| Principal Investigator: | . ., . | . |
More Information
| Study ID Numbers: | 116A, AI455-019 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00002307 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Zidovudine Stavudine |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine 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 HIV Infections Sexually Transmitted Diseases Lentivirus Infections |