Clinical Trials

MainTitle

A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

This study has been completed
Sponsor
Stanford University


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002111

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: May 1995
History of Changes
Purpose

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 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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:

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Stanford University  
ClinicalTrials.gov 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
Saquinavir
HIV Protease Inhibitors

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Protease Inhibitors
Saquinavir
HIV Protease Inhibitors

ClinicalTrials.gov processed this data on November 20, 2017
This information is provided by ClinicalTrials.gov.