ClinicalTrials.Veeva

Menu

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

P

Pharmacia & Upjohn

Status and phase

Completed
Phase 2

Conditions

HIV Infections

Treatments

Drug: Atevirdine mesylate
Drug: Zidovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002322
M/3330/0018
210A

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

12

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems