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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Telinavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telinavir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors