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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002322
• Other study ID #: 210A
• Secondary ID: M/3330/0018
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atevirdine mesylate

• Zidovudine

Locations

Country	Name	City	State
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	Park Plaza Hosp	Houston	Texas
United States	Los Angeles County / Health Research Assoc / Drew Med Ctr	Los Angeles	California
United States	Wisconsin Community - Based Research Consortium	Milwaukee	Wisconsin
United States	UCI Med Ctr	Orange	California
United States	Mem Hosp of Rhode Island	Pawtucket	Rhode Island
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	Davies Med Ctr	San Francisco	California
United States	Infectious Disease Research Institute Inc	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacia and Upjohn

Country where clinical trial is conducted

United States,