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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002333 |
Purpose
To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Saquinavir Drug: Zalcitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy |
| Estimated Enrollment: | 900 |
Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Required:
Contacts and Locations
Hide Study Locations| United States, California | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Davies Med Ctr / c/o HIV Institute | |
| San Francisco, California, United States, 94114 | |
| Mount Zion Med Ctr / UCSF | |
| San Francisco, California, United States, 94115 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90505 | |
| Pacific Oaks Med Group / Rsch & Scientific Investigation | |
| Sherman Oaks, California, United States, 91403 | |
| Kaiser Foundation Hosp | |
| Harbor City, California, United States, 90710 | |
| Sunnyvale Med Clinic | |
| Sunnyvale, California, United States, 94086 | |
| CARE Ctr / UCLA Med Ctr | |
| Los Angeles, California, United States, 90095 | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 900121973 | |
| UCSD | |
| La Jolla, California, United States, 920930679 | |
| UCD | |
| Sacramento, California, United States, 95817 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| Miami Veterans Administration Med Ctr | |
| Miami, Florida, United States, 33125 | |
| Univ of Miami Dept of Medicine | |
| Miami, Florida, United States, 33136 | |
| Stratogen of South Florida | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Georgia | |
| West Paces Clinical Research Incoporated | |
| Atlanta, Georgia, United States, 30327 | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Massachusetts Gen Hosp / Harvard Med School | |
| Boston, Massachusetts, United States, 02114 | |
| New England Deaconess Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Harper Hosp | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Washington Univ School of Medicine | |
| St. Louis, Missouri, United States, 63108 | |
| United States, New Jersey | |
| UMDNJ - New Jersy Med School | |
| Newark, New Jersey, United States, 08103 | |
| UMDNJ - New Jersey Med School / Cooper Hosp | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Harkness Pavilion | |
| New York, New York, United States, 10032 | |
| Albany Med College | |
| Albany, New York, United States, 12208 | |
| United States, Ohio | |
| Ohio State Univ Hosp | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health Sciences Univ | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Thomas Jefferson Med College | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Graduate Hosp / Tuttleman Cancer Ctr | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| United States, Tennessee | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77005 | |
| Oaklawn Physicians Group | |
| Dallas, Texas, United States, 75219 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 775550882 | |
| United States, Washington | |
| Univ of Washington / Harborview Med Ctr | |
| Seattle, Washington, United States, 98104 | |
| Canada, Alberta | |
| Southern Alberta HIV Clinic | |
| Calgary, Alberta, Canada | |
| Canada, Ontario | |
| Sunnybrook Health Science Ctr | |
| Toronto, Ontario, Canada | |
| McMaster Univ Med Ctr | |
| Hamilton, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Gen Hosp | |
| Montreal, Quebec, Canada | |
| Clinique Medicale L'Actuele | |
| Montreal, Quebec, Canada | |
| Puerto Rico | |
| San Juan Veterans Administration Med Ctr | |
| San Juan, Puerto Rico, 009275800 | |
More Information
| Study ID Numbers: | 229A, NV 14256B, NV 14256A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002333 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Zalcitabine Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Saquinavir HIV Protease Inhibitors |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Zalcitabine Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |