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

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT00002111

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Saquinavir	Phase 1

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.

Study Design

Study Type:

Interventional

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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.