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A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
This study has been completed.
Sponsored by: Stanford University
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002111
  Purpose

To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.


Condition Intervention Phase
HIV Infections
Drug: Saquinavir
Phase I

MedlinePlus related topics: AIDS
Drug Information available for: Saquinavir Saquinavir mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study
Official Title: A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

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

Estimated Enrollment: 32
Detailed Description:

Cohorts of 16 patients receive 1 of 2 doses of Ro 31-8959 for 20 weeks. Administration of the higher dose will proceed only after 2-week safety data for the first eight patients on the lower dose has been reviewed.

  Eligibility

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

Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4 count 200 - 500 cells/mm3.
  • No evidence of viral resistance.
  • HIV RNA quantifiable by PCR.
  • Negativity for HBsAg, HBeAg, and anti-HBc.

NOTE:

  • Fifty percent of patients must have measurable p24 antigen levels (> 31 pg/ml).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active opportunistic infection requiring immediate treatment, such as tuberculosis, cytomegalovirus, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
  • Unable to maintain adequate oral intake.
  • Clinically significant vomiting and/or diarrhea.
  • Malignancy, visceral Kaposi's sarcoma, or lymphoma that will require systemic chemotherapy within the next 12 months.
  • Unable to comply with protocol requirements, in the judgment of the investigator.
  • Any grade 3 or worse laboratory or clinical abnormality.

Concurrent Medication:

Excluded:

  • Antineoplastic agents.
  • Concomitant or maintenance treatment with excluded experimental drugs and drugs with known nephrotoxic or hepatotoxic potential.

Concurrent Treatment:

Excluded:

  • Radiation therapy other than local skin radiation therapy.

Patients with the following prior conditions are excluded:

  • Unexplained temperature >= 38.5 C (101.5 F) persisting for 14 days or more within a 30-day period.
  • Unexplained, chronic diarrhea persisting for 14 days or more within a 30-day period.

Prior Medication:

Excluded:

  • Prior treatment with an HIV proteinase inhibitor.
  • AZT within 30 days prior to study entry OR lasting more than 1 year.
  • Other antiretroviral therapy (besides AZT) within 30 days prior to study entry OR lasting more than 14 days.
  • Acute therapy for an opportunistic infection within 14 days prior to study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002111

Locations
United States, California
Stanford Univ School of Medicine
Stanford, California, United States, 943055107
Sponsors and Collaborators
Stanford University
  More Information

Publications:
Study ID Numbers: 212A, EV 14757
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002111  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Complex
Saquinavir
HIV Protease Inhibitors

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Saquinavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
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
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009