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
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: Atevirdine mesylate
Drug: Zidovudine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002322

Locations
United States, California
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, United States, 90033
UCI Med Ctr
Orange, California, United States, 92668
Davies Med Ctr
San Francisco, California, United States, 94114
United States, Florida
Infectious Disease Research Institute Inc
Tampa, Florida, United States, 33614
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 212052196
United States, Massachusetts
Boston City Hosp / FGH-1
Boston, Massachusetts, United States, 02118
United States, New Jersey
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States, 07018
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Texas
Park Plaza Hosp
Houston, Texas, United States, 77004
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
United States, Wisconsin
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, United States, 53202
Sponsors and Collaborators
Pharmacia and Upjohn
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002322     History of Changes
Other Study ID Numbers: 210A, M/3330/0018
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Atevirdine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 27, 2014