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A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
This study has been completed.

First Received on November 2, 1999.   Last Updated on June 23, 2005   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000806
  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 I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012