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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: HIV Protease Inhibitors; Protease Inhibitors; Saquinavir

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.