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A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

This study has been completed.

Sponsored by: Pharmacia and Upjohn
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002123
  Purpose

To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.


Condition Intervention Phase
HIV Infections
Drug: Delavirdine mesylate
Drug: Didanosine
Phase III

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Delavirdine mesylate    Delavirdine    Didanosine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
Official Title:   A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
  Eligibility
Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • AZT.

Patients must have:

  • HIV-1 seropositivity.
  • CD4 count <= 300 cells/mm3.
  • No active or acute (onset within the past month) opportunistic infections such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, or cytomegalovirus (CMV).
  • Consent of parent or guardian if less than 18 years of age.
  • Understanding of potential risk to fetus related to study participation.
  • Acceptable medical history, physical exam, EKG, and chest x-ray during screening.

NOTE:

  • Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active tuberculosis that is sensitive to rifampin.
  • Inability to swallow numerous tablets.
  • Clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy.
  • Clinically significant hypersensitivity to piperazine-type drugs (e.g., Antepar and Stelazine).
  • Grade 2 or worse baseline organ function. NOTE:
  • Hemophiliacs with grade 2 bilirubin, alkaline phosphatase, SGOT, or SGPT will be considered if these values have been stable over the past year. NOTE:
  • Patients with suspected Gilbert's syndrome will be considered if bilirubin is grade 2 or better.

Patients with the following prior conditions are excluded:

  • History of pancreatitis within the past 2 years.
  • History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychiatric disorder that would preclude study compliance.
  • History of grade 2 or worse peripheral neuropathy.
  • Intolerance to ddI in previous treated patients.

Prior Medication:

Excluded:

  • More than 4 months total of prior ddI.
  • Any prior ddC, d4T, or 3TC.
  • Prior nonnucleoside reverse transcriptase inhibitors, including L-drugs, nevirapine, TIBO, HEPT, delavirdine, atevirdine, and alpha-APA.
  • Other investigational antiretroviral medications (including foscarnet) or immunomodulators (including all interferons) within 21 days prior to initial study drug dose.
  • Prior prophylactic or therapeutic HIV-1 gp120 or 160 vaccines.
  • Rifampin, rifabutin, astemizole, loratadine, or terfenadine within 21 days prior to initial study drug dose.
  • Any unapproved investigational medication for any indication within 21 days prior to initial study drug dose.

Required:

  • AZT therapy at some time prior to screening. Active substance abuse.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002123

Show 84 study locations  Show 84 Study Locations

Sponsors and Collaborators
Pharmacia and Upjohn
  More Information


Publications:
Freimuth WW, Chuang-Stein CJ, Greenwald CA, Cox SR, Edge-Padbury BA, Carberry PA, Wathen LK. Delavirdine (DLV) + didanosine (ddI) combination therapy has sustained surrogate marker response in advanced HIV-1 population. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:163
 

Study ID Numbers:   228A, M/3331/0017
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002123
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Didanosine
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Delavirdine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2008




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