Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-08 @ 12:10 PM
Study NCT ID:
NCT00000995
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D054069', 'term': 'Multiple Acyl Coenzyme A Dehydrogenase Deficiency'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D015774', 'term': 'Ganciclovir'}], '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': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1990-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS-Related Opportunistic Infections', 'Ganciclovir', 'Drug Evaluation', 'Drug Therapy, Combination', 'Cytomegalovirus Infections', 'Acquired Immunodeficiency Syndrome', 'Zidovudine'], 'conditions': ['Cytomegalovirus Infections', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '2163228', 'type': 'BACKGROUND', 'citation': 'Hochster H, Dieterich D, Bozzette S, Reichman RC, Connor JD, Liebes L, Sonke RL, Spector SA, Valentine F, Pettinelli C, et al. Toxicity of combined ganciclovir and zidovudine for cytomegalovirus disease associated with AIDS. An AIDS Clinical Trials Group Study. Ann Intern Med. 1990 Jul 15;113(2):111-7. doi: 10.7326/0003-4819-113-2-111.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical and laboratory toxicity of ganciclovir (GCV) and zidovudine (AZT) when given in combination.\n\nBecause recent information has shown AZT to be useful in treating AIDS, it is assumed that most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT. Because AZT is reported not to be active against cytomegalovirus (CMV), it is important to see if it is useful to give GCV along with AZT.', 'detailedDescription': 'Because recent information has shown AZT to be useful in treating AIDS, it is assumed that most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT. Because AZT is reported not to be active against cytomegalovirus (CMV), it is important to see if it is useful to give GCV along with AZT.\n\nPatients are placed into one of four groups at entry into study according to their previous treatment:\n\nI: Prior treatment with AZT up to the time of developing CMV infection and not requiring dose reduction of AZT for toxicity.\n\nII: Prior treatment with AZT up to the time of developing CMV infection and requiring dose reduction of AZT for toxicity.\n\nIII: Prior therapy with GCV for CMV infection. These patients should already be in the maintenance phase, having completed a minimum of 2 weeks of induction therapy.\n\nIV: No prior therapy with either AZT or GCV.\n\nTreatment lasts 24 weeks and consists of two treatment plans:\n\nA: Patients not previously treated with GCV are started on GCV for an additional 22 weeks. GCV is given as a 1-hour infusion. All patients are started on AZT at the lowest dose. B: For patients with chronic CMV disease who are receiving GCV maintenance, GCV is administered as a 1-hour infusion 5 days/week.\n\nAZT is added and treatment with GCV is standardized prior to beginning of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Symptomatic therapy such as analgesics, antihistamines, antiemetics, and antidiarrheal agents, or other supportive therapy may be administered as deemed necessary by the responsible investigator. For fever, the following regimens should be used:\n* If fever above 39.0 degrees C, antipyretic therapy will be administered employing aspirin, 650 mg orally every 4 hours x 3 doses, or until fever falls below 39.0 degrees C.\n* If fever of higher than 39.0 degrees C occurs for 2 consecutive days, the patient may be premedicated with aspirin.\n\nExclusion Criteria\n\n* Active alcohol or drug abuse.\n\nCo-existing Condition:\n\nExcluded:\n\n* Patients with other life-threatening and uncontrolled opportunistic infections on enrollment.\n\nPatients with the following prior conditions are excluded if they:\n\n* Have other life-threatening and uncontrolled opportunistic infections on enrollment.\n\nPrior Medication:\n\nExcluded within 1 week of study entry:\n\n* Systemic therapy with antimetabolite.\n* Cytotoxic drug.\n* Interferon.\n* Immunologic modulators.\n* Corticosteroids.\n* Nucleoside analogs other than zidovudine (AZT).\n* Excluded within 2 weeks of study entry:\n* Therapy for any other opportunistic infections.\n* Excluded within 2 months of study entry:\n* Ribavirin.\n\nPrior Treatment:\n\nExcluded within 2 weeks of study entry (for treatment group I):\n\n* Blood transfusion.\n* Excluded within 1 month of study entry (for treatment groups II and III):\n* Blood transfusion.\n\nAll patients must be:\n\n* Able to provide informed consent.\n* Likely to be available for follow-up for at least 4 months.'}, 'identificationModule': {'nctId': 'NCT00000995', 'briefTitle': 'A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection', 'orgStudyIdInfo': {'id': 'ACTG 004'}, 'secondaryIdInfos': [{'id': '10980', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Zidovudine', 'type': 'DRUG'}, {'name': 'Ganciclovir', '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': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hosp / New York Univ Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Reichman RC', 'role': 'STUDY_CHAIR'}, {'name': 'Richman D', 'role': 'STUDY_CHAIR'}, {'name': 'Hochster H', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}