A Phase I Randomized Dose/Formulation Comparison Study of SC-52151

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.

Patients are randomized to four treatment arms to receive SC-52151 elixir or SEDDS formulation at 1 of 2 doses for 2 weeks, with follow-up for 14 days.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Required for patients with CD4 count \<= 200 cells/mm3:
• • PCP prophylaxis using TMP/SMX or aerosolized pentamidine.
• Allowed:
• • Topical antifungal agents.
• • Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus.
• • Antibiotics for bacterial infections.
• • Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment.
• Patients must have:
• • HIV infection.
• • CD4 count 150 - 500 cells/mm3.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Unable to tolerate the standard diet required for the study.
• • Unable to give informed consent.
• Concurrent Medication:
• Excluded:
• • Antiretrovirals and biologic response modifiers (including HIV vaccines).
• • Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
• • Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
• • Allopurinol.
• • Omeprazole.
• • Astemizole.
• • Terfenadine.
• • Loratadine.
• • Psychotropics.
• • Phenylbutazone.
• • Barbiturates.
• • Benzodiazepines.
• • Monoamine oxidase inhibitors.
• • H-2 blockers.
• • Anticonvulsants.
• • Coumadin anticoagulants.
• • Oral contraceptives.
• • Antiarrhythmics.
• • Diltiazem.
• • Metronidazole.
• • Erythromycin.
• • Chloramphenicol.
• • Fluoroquinolones.
• • Disulfiram.
• • Erythropoietin.
• • G-CSF or GM-CSF.
• • Systemic corticosteroids.
• • Alcohol, including alcohol-containing medications.
• Patients with the following prior conditions are excluded:
• • Unexplained temperature \>= 38.5 C for any 7 days within the 30 days prior to study entry.
• • Chronic diarrhea (\>= three stools per day) for any 15 days within the 30 days prior to study entry.
• • Malignancy other than basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, and minimal Kaposi's sarcoma.
• Prior Medication:
• Excluded at any time:
• • Prior HIV protease inhibitor.
• Excluded within 30 days prior to study entry:
• • Investigational drugs.
• • Recombinant erythropoietin.
• • G-CSF or GM-CSF.
• • Interferon or interleukin.
• • Any HIV-1 vaccine.
• Excluded within 14 days prior to study entry:
• • Antiretrovirals.
• • Acute therapy for any opportunistic or other serious infection.
• • Therapy for malignancy.
• • Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
• • Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
• Excluded within 7 days prior to study entry:
• • Allopurinol.
• • Omeprazole.
• • Astemizole.
• • Terfenadine.
• • Loratadine.
• • Psychotropics.
• • Phenylbutazone.
• • Barbiturates.
• • Benzodiazepines.
• • Monoamine oxidase inhibitors.
• • H-2 blockers.
• • Anticonvulsants.
• • Coumadin anticoagulants.
• • Oral contraceptives.
• • Antiarrhythmics.
• • Diltiazem.
• • Metronidazole.
• • Erythromycin.
• • Chloramphenicol.
• • Fluoroquinolones.
• • Disulfiram.
• Risk Behavior: Excluded:
• • History of substance or alcohol abuse.
• • Ingestion of more than 50 g alcohol daily within 6 months prior to study entry.
• • Recovered alcoholic.