A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
This study has been completed.
Sponsor:
Pharmacia and Upjohn
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002322
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1996
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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 2 |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Zidovudine
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Primary or secondary prophylaxis for opportunistic infections.
Patients must have:
- HIV infection.
- Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED:
- Cryptococcosis
- Pneumocystis carinii pneumonia
- Herpes zoster
- Histoplasmosis
- CMV
- Hepatic or renal disease
- Lymphoma.
- CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry.
- Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry.
- Consent of parent, guardian, or person with power of attorney if less than 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
- Intolerance to AZT.
- Current diagnosis of malignancy for which systemic therapy will be required during the study.
Concurrent Medication:
Excluded:
- Any other investigational drugs.
Prior Medication:
Excluded:
- Cytotoxic chemotherapy within 1 month prior to study entry.
- Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors.
- Antiretroviral agents other than AZT within 3 months prior to study entry.
Required:
- AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002322
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 | |
Sponsors and Collaborators
Pharmacia and Upjohn
More Information
No publications provided
| 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 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 19, 2013