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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Telinavir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of California / San Diego Treatment Ctr
  • Univ of Miami School of Medicine
  • Johns Hopkins Hosp
  • Ohio State Univ Hosp Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000806
Brief Title
A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
Official Title
A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
Study Type
Interventional

2. Study Status

Record Verification Date
February 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Telinavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fischl MA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richman DD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Flexner C
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Para MF
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
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A Phase I Randomized Dose/Formulation Comparison Study of SC-52151

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