Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT00000806
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1995-02', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'HIV Protease Inhibitors'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', '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'}]}, 'descriptionModule': {'briefSummary': 'PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151.\n\nSECONDARY: 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.\n\nSince 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.', 'detailedDescription': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nRequired for patients with CD4 count \\<= 200 cells/mm3:\n\n* PCP prophylaxis using TMP/SMX or aerosolized pentamidine.\n\nAllowed:\n\n* Topical antifungal agents.\n* Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus.\n* Antibiotics for bacterial infections.\n* Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment.\n\nPatients must have:\n\n* HIV infection.\n* CD4 count 150 - 500 cells/mm3.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Unable to tolerate the standard diet required for the study.\n* Unable to give informed consent.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretrovirals and biologic response modifiers (including HIV vaccines).\n* Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.\n* Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.\n* Allopurinol.\n* Omeprazole.\n* Astemizole.\n* Terfenadine.\n* Loratadine.\n* Psychotropics.\n* Phenylbutazone.\n* Barbiturates.\n* Benzodiazepines.\n* Monoamine oxidase inhibitors.\n* H-2 blockers.\n* Anticonvulsants.\n* Coumadin anticoagulants.\n* Oral contraceptives.\n* Antiarrhythmics.\n* Diltiazem.\n* Metronidazole.\n* Erythromycin.\n* Chloramphenicol.\n* Fluoroquinolones.\n* Disulfiram.\n* Erythropoietin.\n* G-CSF or GM-CSF.\n* Systemic corticosteroids.\n* Alcohol, including alcohol-containing medications.\n\nPatients with the following prior conditions are excluded:\n\n* Unexplained temperature \\>= 38.5 C for any 7 days within the 30 days prior to study entry.\n* Chronic diarrhea (\\>= three stools per day) for any 15 days within the 30 days prior to study entry.\n* Malignancy other than basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, and minimal Kaposi's sarcoma.\n\nPrior Medication:\n\nExcluded at any time:\n\n* Prior HIV protease inhibitor.\n\nExcluded within 30 days prior to study entry:\n\n* Investigational drugs.\n* Recombinant erythropoietin.\n* G-CSF or GM-CSF.\n* Interferon or interleukin.\n* Any HIV-1 vaccine.\n\nExcluded within 14 days prior to study entry:\n\n* Antiretrovirals.\n* Acute therapy for any opportunistic or other serious infection.\n* Therapy for malignancy.\n* Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.\n* Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.\n\nExcluded within 7 days prior to study entry:\n\n* Allopurinol.\n* Omeprazole.\n* Astemizole.\n* Terfenadine.\n* Loratadine.\n* Psychotropics.\n* Phenylbutazone.\n* Barbiturates.\n* Benzodiazepines.\n* Monoamine oxidase inhibitors.\n* H-2 blockers.\n* Anticonvulsants.\n* Coumadin anticoagulants.\n* Oral contraceptives.\n* Antiarrhythmics.\n* Diltiazem.\n* Metronidazole.\n* Erythromycin.\n* Chloramphenicol.\n* Fluoroquinolones.\n* Disulfiram.\n\nRisk Behavior: Excluded:\n\n* History of substance or alcohol abuse.\n* Ingestion of more than 50 g alcohol daily within 6 months prior to study entry.\n* Recovered alcoholic."}, 'identificationModule': {'nctId': 'NCT00000806', 'briefTitle': 'A Phase I Randomized Dose/Formulation Comparison Study of SC-52151', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase I Randomized Dose/Formulation Comparison Study of SC-52151', 'orgStudyIdInfo': {'id': 'ACTG 282'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Telinavir', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '921036325', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Univ of California / San Diego Treatment Ctr', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '331361013', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hosp', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '432101228', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Univ Hosp Clinic', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Fischl MA', 'role': 'STUDY_CHAIR'}, {'name': 'Richman DD', 'role': 'STUDY_CHAIR'}, {'name': 'Flexner C', 'role': 'STUDY_CHAIR'}, {'name': 'Para MF', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}}}}