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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002334 |
Purpose
To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Saquinavir Drug: Zidovudine Drug: Zalcitabine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3 |
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 condition are excluded:
History of non-Hodgkin's lymphoma.
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| UCD Med Ctr | |
| Sacramento, California, United States, 95817 | |
| Sunnyvale Med Clinic | |
| Sunnyvale, California, United States, 94086 | |
| Mount Zion Med Ctr / UCSF | |
| San Francisco, California, United States, 94115 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Pacific Oaks Med Group | |
| Sherman Oaks, California, United States, 91403 | |
| United States, District of Columbia | |
| Howard Univ | |
| Washington, District of Columbia, United States, 20060 | |
| Novum Inc | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| Miami Veterans Administration Med Ctr | |
| Miami, Florida, United States, 33125 | |
| 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, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Massachusetts | |
| Massachusetts Gen Hosp | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Nevada | |
| HIV Wellness Ctr / Univ Med Ctr | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New York | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Harkness Pavilion | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Univ Hosp of Cleveland / Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oklahoma | |
| Univ of Oklahoma Health Science / Pharmacy Practice | |
| Oklahoma City, Oklahoma, United States, 73117 | |
| United States, Pennsylvania | |
| Novum Inc | |
| Pittsburgh, Pennsylvania, United States, 152063817 | |
| United States, Texas | |
| N Texas Ctr for AIDS & Clin Rsch | |
| Dallas, Texas, United States, 75219 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 775550882 | |
| Thomas Street Clinic / Baylor College of Medicine | |
| Houston, Texas, United States, 77009 | |
| Respiratory Associates | |
| Corpus Christi, Texas, United States, 78404 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224379 | |
| Puerto Rico | |
| San Juan Veterans Administration Med Ctr | |
| San Juan, Puerto Rico, 009275800 | |
More Information
| Study ID Numbers: | 229B, SV 14604C, SV 14604A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002334 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Zidovudine Saquinavir HIV Protease Inhibitors |
|
Antimetabolites 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 Zalcitabine Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |