Search / Trial NCT00000806

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

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

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Hiv Protease Inhibitors

Description

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.

Attachments

readout_NCT00000806_2024-03-02.pdf

4.5 MB

NCT00000806_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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