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

This study has been completed.
Sponsor:
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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002322 on ClinicalTrials.gov Archive Site
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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

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).

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.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Atevirdine mesylate
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002322
210A, M/3330/0018
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Pharmacia and Upjohn
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NIH AIDS Clinical Trials Information Service
November 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP