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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002111
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1995

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002111 on ClinicalTrials.gov Archive Site
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A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Saquinavir
Not Provided
Schapiro JM, Winters MA, Stewart F, Efron B, Norris J, Kozal MJ, Merigan TC. The effect of high-dose saquinavir on viral load and CD4+ T-cell counts in HIV-infected patients. Ann Intern Med. 1996 Jun 15;124(12):1039-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002111
212A, EV 14757
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Stanford University
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NIH AIDS Clinical Trials Information Service
May 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP