Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT00001057
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
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': 'D015215', 'term': 'Zidovudine'}, {'id': 'D016049', 'term': 'Didanosine'}], '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'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1995-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Didanosine', 'Drug Therapy, Combination', 'Zidovudine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 counts greater than or equal to 550 cells/mm3.\n\nRecent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.', 'detailedDescription': 'Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.\n\nPatients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antibiotics for bacterial infections as clinically indicated.\n* Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively.\n* Antipyretics.\n* Analgesics.\n* Allergy medications.\n* Oral contraceptives.\n* Nonprescription medications such as vitamins or herbal therapies.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Radiation therapy to local lesion only.\n* Acupuncture.\n\nPatients must have:\n\n* HIV seropositivity.\n* CD4 count \\>= 550 cells/mm3.\n* No ARC or AIDS conditions by CDC criteria.\n* Consent of parent or guardian if less than 18 years of age.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Presence of factors predisposing to pancreatitis such as active alcoholism.\n* Other medical conditions that would interfere with study compliance.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other antiretrovirals or systemic immunomodulators.\n* Systemic corticosteroids.\n* Systemic cytotoxic chemotherapy.\n* Intravenous pentamidine.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy except to local lesion.\n\nPatients with the following prior conditions are excluded:\n\n* History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month.\n* History of grade 2 or worse peripheral neuropathy.\n* History of pancreatitis.\n* Bacterial infection requiring antibiotics within 14 days prior to study entry.\n\nPrior Medication:\n\nExcluded:\n\n* Prior HIV therapy with antiretrovirals or systemic immunomodulators.\n\nPrior Treatment:\n\nExcluded within 2 weeks prior to study entry:\n\n* Transfusion.\n\nActive substance abuse or alcoholism.'}, 'identificationModule': {'nctId': 'NCT00001057', 'briefTitle': 'The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3', 'orgStudyIdInfo': {'id': 'ACTG 275'}, 'secondaryIdInfos': [{'id': '11251', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Zidovudine', 'type': 'DRUG'}, {'name': 'Didanosine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Med Clinic', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Univ of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'St Paul Ramsey Med Ctr', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '681985130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Univ of Nebraska Med Ctr', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve Univ', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '191075098', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson Univ Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '775550435', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Erice A', 'role': 'STUDY_CHAIR'}, {'name': 'Balfour H', 'role': 'STUDY_CHAIR'}, {'name': 'Carey J', 'role': 'STUDY_CHAIR'}, {'name': 'Henry K', 'role': 'STUDY_CHAIR'}, {'name': 'Hasse A', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}