A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00002322

Run by

Pharmacia and Upjohn

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles County / Health Research Assoc / Drew Med Ctr — Los Angeles, California, United States
• UCI Med Ctr — Orange, California, United States
• Davies Med Ctr — San Francisco, California, United States
• Infectious Disease Research Institute Inc — Tampa, Florida, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Boston City Hosp / FGH-1 — Boston, Massachusetts, United States
• East Orange Veterans Administration Med Ctr — East Orange, New Jersey, United States
• Buckley Braffman Stern Med Associates — Philadelphia, Pennsylvania, United States
• Mem Hosp of Rhode Island — Pawtucket, Rhode Island, United States
• Park Plaza Hosp — Houston, Texas, United States
• Univ TX San Antonio Health Science Ctr — San Antonio, Texas, United States
• Wisconsin Community - Based Research Consortium — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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