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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002322
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

Brief 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).

Detailed 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.

Interventions

DRUGAtevirdine mesylate
DRUGZidovudine

Sponsors

Pharmacia and Upjohn
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026