A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of June 22, 2025
Completed
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
San Diego, California, United States
Miami, Florida, United States
Baltimore, Maryland, United States
Patients applied
Trial Officials
Fischl MA
Study Chair
Richman DD
Study Chair
Flexner C
Study Chair
Para MF
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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