A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
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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
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Fifty percent of patients must have measurable p24 antigen levels (> 31 pg/ml).
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.
Concomitant or maintenance treatment with excluded experimental drugs and drugs with known nephrotoxic or hepatotoxic potential.
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 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.