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A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

This study has been completed.

Sponsored by: Pharmacia and Upjohn
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002401
  Purpose

The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Delavirdine mesylate
Drug: Lamivudine
Drug: Zidovudine

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Lamivudine    Indinavir    Indinavir Sulfate    Delavirdine mesylate    Delavirdine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals

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

Estimated Enrollment:   160

Detailed Description:

In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:

Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.

  • Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
  Eligibility
Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior indinavir.
  • Prior lamivudine.
  • Prior protease inhibitors.
  • Prior non-nucleoside reverse transcriptase inhibitors.
  • 1 month or more prior zidovudine.

    1. HIV-1 positive.

  • CD4 coun tis above 50.
  • HIV-1 RNA levels greater than 20,000.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002401

Locations
United States, New Jersey
Pharmacia & Upjohn    
      Peapack, New Jersey, United States, 07977

Sponsors and Collaborators
Pharmacia and Upjohn
  More Information


Study ID Numbers:   228F, 0074
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002401
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1  
Zidovudine  
HIV Protease Inhibitors  
Lamivudine  
Indinavir  
RNA, Viral
Delavirdine
Reverse Transcriptase Inhibitors
Viral Load

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Indinavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Delavirdine
Retroviridae Infections
Immunologic Deficiency Syndromes

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

ClinicalTrials.gov processed this record on December 03, 2008




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