HIV Infections
Conditions
Keywords
AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors
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.
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.
Interventions
DRUGSaquinavir
Sponsors
Stanford University
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed