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

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Stanford University

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Saquinavir

Study type

Interventional

Funder types

Other

Identifiers

NCT00002111
212A
EV 14757

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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