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A Study of 141W94 in Combination With Other Anti-HIV Drugs

This study has been completed.

Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002372
  Purpose

To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing. To determine the steady-state pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when combined with saquinavir, indinavir and nelfinavir.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Amprenavir
Drug: Nelfinavir mesylate
Drug: Saquinavir
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Indinavir    Indinavir Sulfate    Nelfinavir    Nelfinavir Mesylate    Saquinavir    Saquinavir mesylate    VX 478   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   A Phase I/II Screening Trial to Identify Potential Partner Compounds to Use in Combination With 141W94

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

Estimated Enrollment:   48

Detailed Description:

Patients will be randomized to receive open label 141W94 in combination with saquinavir, indinavir and nelfinavir. The randomized phase will be preceded by a single dose pharmacokinetic interaction study of 141W94 and indinavir in 12 patients. Data from this single dose investigation will be used to determine the dose of indinavir to be used in the randomized phase.

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed provided used with caution:

Medications that may interact at CYP3A4 (either a substrate, inhibitor or inducer of the enzyme) should be used with caution.

Patients must have:

  • Documented HIV infection.
  • CD4+ cell count >= 200 cells/mm3.

    1. Anticipated need for treatment with cytotoxic chemotherapeutic agents within the study time period.

  • Treatment with immunomodulating agents.
  • Medications that should not be administered with 141W94:

Terfenadine. Astemizole. Cisapride. Triazolam. Midazolam. Ergotamine/Dihydroergotamine-containing regimens. Antiretroviral drugs. Vitamin E supplements. Other experimental agents.

Anticipated need for radiation therapy within the study time period.

1. Prior protease inhibitors.

  • Antiretroviral therapy within 2 weeks prior to entry.
  • Treatment with cytotoxic chemotherapeutic agents within 4 weeks prior to entry.

Radiation therapy within 4 weeks prior to entry. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing and protocol evaluations.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002372

Locations
United States, California
Univ of California / San Diego Treatment Ctr    
      San Diego, California, United States, 92103
ViRx Inc    
      San Francisco, California, United States, 94109
United States, North Carolina
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr    
      Durham, North Carolina, United States, 27710

Sponsors and Collaborators
Glaxo Wellcome
  More Information


Publications:

Study ID Numbers:   264A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002372
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
Administration, Oral  
HIV Protease Inhibitors  
Indinavir  
Saquinavir
Nelfinavir
VX 478

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

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Anti-Bacterial Agents
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on December 03, 2008




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