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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000806
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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.


Condition Intervention Phase
HIV Infections Drug: Telinavir Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase I Randomized Dose/Formulation Comparison Study of SC-52151

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 48
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000806


Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Ohio
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Fischl MA
Study Chair: Richman DD
Study Chair: Flexner C
Study Chair: Para MF
  More Information

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

ClinicalTrials.gov Identifier: NCT00000806     History of Changes
Other Study ID Numbers: ACTG 282
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: February 1995

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
HIV Protease Inhibitors

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases