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

June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 921036325
        • Univ of California / San Diego Treatment Ctr
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • Ohio
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Richman DD
  • Study Chair: Flexner C
  • Study Chair: Para MF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Fischl MA, Richman DD, Flexner C, Meehan P, Para MF, Haubrich R, Cook J, Wood K, Karim A. Phase I study of two formulations and dose schedules of SC- 521151, A protease inhibitor. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:88

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 282

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe