Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT00002260
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C002854', 'term': 'alovudine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1992-03', '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': ['Biological Availability', 'alovudine', 'Food'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* Positive ELISA test confirmed by Western blot analysis.\n* Asymptomatic.\n* Willing to sign an informed consent.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.\n* Oral hairy leukoplakia at any time prior to entry.\n* Temperature \\> 37.8 C.\n* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.\n* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.\n* Unwilling to sign an informed consent.\n* Zidovudine induced hematological toxicity.\n\nPrior Medication:\n\nExcluded:\n\n* Therapy with antiretroviral drugs or immunomodulators within seven days before entry.\n* Therapy with any investigational drug during the preceding 30 days.\n\nPatients may not have:\n\n* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.\n* Oral hairy leukoplakia at any time prior to entry.\n* Temperature \\> 37.8 C.\n* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.\n* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.\n* Unwilling to sign an informed consent.\n* Zidovudine induced hematological toxicity.'}, 'identificationModule': {'nctId': 'NCT00002260', 'briefTitle': "An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects", 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': "An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects", 'orgStudyIdInfo': {'id': '054C'}, 'secondaryIdInfos': [{'id': '81-3'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Alovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hosp', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lederle Laboratories', 'class': 'INDUSTRY'}}}}