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| Sponsor: | Pharmacia and Upjohn |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002322 |
Purpose
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Atevirdine mesylate Drug: Zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients |
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 conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Required:
Contacts and Locations| United States, California | |
| Los Angeles County / Health Research Assoc / Drew Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| United States, Florida | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 212052196 | |
| United States, Massachusetts | |
| Boston City Hosp / FGH-1 | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New Jersey | |
| East Orange Veterans Administration Med Ctr | |
| East Orange, New Jersey, United States, 07018 | |
| United States, Pennsylvania | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| Mem Hosp of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, Texas | |
| Park Plaza Hosp | |
| Houston, Texas, United States, 77004 | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
| United States, Wisconsin | |
| Wisconsin Community - Based Research Consortium | |
| Milwaukee, Wisconsin, United States, 53202 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002322 History of Changes |
| Other Study ID Numbers: | 210A, M/3330/0018 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |