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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002372
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
History of Changes
  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 1

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

Resource links provided by NLM:

U.S. FDA Resources

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:

ClinicalTrials.gov Identifier: NCT00002372     History of Changes
Other Study ID Numbers: 264A
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
Administration, Oral
HIV Protease Inhibitors
Indinavir
 Saquinavir
Nelfinavir
VX 478

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
HIV Protease Inhibitors
Indinavir
Saquinavir
 Nelfinavir
Amprenavir
Anti-HIV Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on May 19, 2013