The Safety and Effectiveness of U-90152 in HIV-1 Infected Patients Who Take Zidovudine

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002312
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1994
  Purpose

To evaluate the pharmacokinetics, safety, and tolerance of delavirdine mesylate ( U-90152 ) after multiple doses given orally to asymptomatic HIV-1 positive patients who are maintained on a stable dose of zidovudine ( AZT ). To investigate the optimum dose regimen of U-90152 that gives average trough concentrations > 1 micromolar in combination with standard AZT therapy, and to examine drug interactions between the two drugs. To establish the MTD of U-90152 in HIV-1 positive patients on stable AZT therapy. To investigate comparative pharmacokinetics between HIV-1 positive men and women.


Condition Intervention
HIV Infections
Drug: Delavirdine mesylate
Drug: Zidovudine

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Escalating Multiple-Dose Study of the Safety, Tolerance, and Pharmacokinetics of Oral U-90152 in HIV-1 Infected Males and Females With CD4 Counts of 200 - 500 Cells/mm3 Who Are Maintained on a Stable Dose of Zidovudine (AZT)

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Inhaled pentamidine following completion of the inpatient pharmacokinetic portion of the study.

Patients must have:

  • HIV-1 infection.
  • CD4 count 200 - 500 cells/mm3.
  • Maintenance on AZT for at least 6 weeks.
  • No active opportunistic infections.
  • Ability to swallow numerous tablets without difficulty.
  • Ability to have blood samples drawn.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Acute medical problems, including opportunistic infections (such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, CMV) and nonopportunistic diseases (liver and renal disease, orthostatic hypotension, hypertension, progressive multifocal leukoencephalopathy, lymphoma, Kaposi's sarcoma, or other malignancy).
  • Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine, and U-87201E).
  • Negative EMIT drug screen or equivalent for drugs of abuse.

Concurrent Medication:

Excluded:

  • Antiretroviral agents other than AZT.
  • Primary or secondary prophylactic medications for opportunistic infections (inhaled pentamidine is permitted following completion of the inpatient pharmacokinetic portion of the study).

Patients with the following prior conditions are excluded:

  • History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychotic disorder that might impair study compliance.
  • History of clinically significant cardiovascular, renal, hepatic, cardiac, pulmonary, endocrine, hematologic, vascular, or collagen disease.

Prior Medication:

Excluded:

  • Prior U-87201E or other non-nucleoside reverse transcriptase inhibitors (nevirapine, TIBO, L-drugs, and HEPT).
  • Antiretroviral agents (other than AZT) or immunomodulating agents within 15 days prior to study entry.
  • Primary prophylactic drugs within 15 days prior to study entry.
  • Any known enzyme-inducing drug or any enzyme-inhibiting agents, such as ketoconazole, fluconazole, rifampin, isoniazid, and cimetidine, within 15 days prior to study entry.
  • Any investigational medication within 15 days prior to study entry. Unwilling to comply with safer sex practices. Active substance abuse. Alcohol consumption during the inpatient pharmacokinetic portion of the study.
  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: NCT00002312

Locations
United States, Michigan
Bronson Methodist Hosp / Upjohn Research Clinic
Kalamazoo, Michigan, United States, 490074949
Sponsors and Collaborators
Pharmacia and Upjohn
  More Information

Publications:
Batts DH, Freimuth WW, Cox SR, Peel BG, Hanover CK, Wathen LK, Staton BA. Open-label escalating multiple-dose study of the safety,tolerance, and pharmacokinetics of oral U-90152S (delavirdine, DLV) in HIV-1 infected males and females with CD4 counts of 200 to 500/mm3, who are maintained on a stable dose of AZT. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:158

ClinicalTrials.gov Identifier: NCT00002312     History of Changes
Other Study ID Numbers: 125A, M/3331/0003
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 Interactions
Antiviral Agents
Zidovudine

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
Delavirdine
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 July 10, 2014