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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.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1995
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 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  • 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:


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

Concurrent Treatment:


  • 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:


  • 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.
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Please refer to this study by its identifier: NCT00002111

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

Publications: Identifier: NCT00002111     History of Changes
Other Study ID Numbers: 212A
EV 14757
Study First Received: November 2, 1999
Last Updated: June 23, 2005

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

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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on May 25, 2017