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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151. SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity. 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.

Key facts

Study ID

NCT00000806

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Last updated by the study team

2005-06-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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