Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00001993
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3
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': 'C059896', 'term': 'miglustat'}, {'id': 'D015215', 'term': 'Zidovudine'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1992-02', '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': ['Drug Therapy, Combination', 'Zidovudine'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '7905523', 'type': 'BACKGROUND', 'citation': 'Fischl MA, Resnick L, Coombs R, Kremer AB, Pottage JC Jr, Fass RJ, Fife KH, Powderly WG, Collier AC, Aspinall RL, et al. The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3. J Acquir Immune Defic Syndr (1988). 1994 Feb;7(2):139-47.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3.\n\nThe secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Medications for the prophylaxis of opportunistic infections, such as:\n* Aerosolized pentamidine.\n* Trimethoprim/sulfamethoxazole.\n* Nystatin.\n* Clotrimazole.\n* Anti-mycobacterial agents.\n* Ganciclovir.\n* Topical acyclovir.\n\nPatients must have the following:\n\n* CD4+ cells counts = or \\> 200 \\< 500 /cell mm3.\n* For purposes of inclusion the absolute CD4+ cell count must be = or \\> 200 \\< 500 cells/mm3 on the first sample and = or \\> 190 \\< 510 cells/mm3 on the second sample.\n* Have at least one of the following:\n* Oral candidiasis.\n* Herpes zoster during the last 3 years.\n* Oral hairy leukoplakia during the past three years.\n* Chronic ( \\> 30 day period), recurrent seborrheic dermatitis, or topical, pruritic folliculitis (itchy bumps).\n* Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight.\n* Chronic fatigue present for the past 6 months, which has interfered with normal activity at least 1 to 2 times per week.\n* HIV antibody positive as determined by federally licensed Enzyme-linked Immunosorbent Assay (ELISA).\n* Documented, written informed consent must be obtained prior to admission to the study.\n\nPrior Medication:\n\nAllowed for no more than 12 weeks prior to study entry:\n\n* Zidovudine (AZT).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Malignancies, with the exception of basal cell carcinoma.\n* Significant organ dysfunction.\n\nConcurrent Medication:\n\nExcluded:\n\n* All anti-retroviral drugs with the exception of Zidovudine. Cancer chemotherapeutic agents.\n* Anti-metabolites and alkylating agents.\n* All investigational non-FDA approved drugs.\n\nPatients with the following are excluded:\n\n* Clinically significant diarrhea (\\> 3 liquid stools per day for \\> 7 days) without definable cause, within 6 months prior to enrollment).\n* Diarrhea, as above, with known, non-HIV related cause occurring within one month prior to enrollment.\n* Meets CDC criteria for AIDS classification.\n* Chronic fever (\\> 38.5 C persisting for more than 14 consecutive days, or for more than 15 days in any 30-day interval prior to study entry).\n* Malignancies, with the exception of basal cell carcinoma.\n* Significant organ dysfunction.\n* Known hypersensitivity to SC-48334 or related compounds.\n* History of lactose intolerance.\n\nPrior Medication:\n\nExcluded within 30 days of study entry:\n\n* Any investigational medication.\n* Treatment with a drug (other than Zidovudine) with anti-HIV activity.\n* Excluded for \\> 12 weeks prior to study entry:\n* Zidovudine (AZT).\n* Excluded within 90 days of study entry:\n* Ribavirin.\n* Excluded within 6 months of study entry:\n* Cancer chemotherapy.\n* Excluded:\n* Treatment with SC-48334.\n\nPrior Treatment:\n\nExcluded within 30 days of study entry:\n\n* Electron beam radiation.\n* Excluded within 6 months prior to study entry:\n* Required HIV-related blood transfusions.\n* Whole body radiation.\n\nCurrent use of illicit substances; or current abuse of alcohol, the use of which would limit compliance with the protocol.'}, 'identificationModule': {'nctId': 'NCT00001993', 'briefTitle': 'Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3', 'orgStudyIdInfo': {'id': '057A'}, 'secondaryIdInfos': [{'id': 'NS8-90-02-004'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Butyldeoxynojirimycin', 'type': 'DRUG'}, {'name': 'Zidovudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '331361013', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Rush Presbyterian - Saint Luke's Med Ctr", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Infectious Diseases Research Clinic / Indiana Univ Hosp', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '432101228', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Univ Hosp Clinic', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Julio Arroyo', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '981224304', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Univ of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'G D Searle', 'class': 'INDUSTRY'}}}}