Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-31 @ 12:23 AM
Study NCT ID:
NCT00002161
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106812', 'term': 'adefovir dipivoxil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1997-05', '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', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Antiviral Agents', 'Adenine'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.', 'detailedDescription': 'Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must have:\n\n* HIV infection with HIV RNA titer \\>= 2500 copies/ml (2.5 KEq/ml) plasma.\n* CD4 count \\>= 200 cells/mm3.\n* No new AIDS-defining event within the past 2 months.\n* Life expectancy at least 1 year.\n* Consent of parent or guardian if less than 18 years old.\n* Tolerated antiretroviral therapy for the past 2 months.\n\nNOTE:\n\n* Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy.\n* Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication.\n* Malignancy other than Kaposi's sarcoma or basal cell carcinoma.\n\nConcurrent Medication:\n\nExcluded:\n\n* Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.\n* Isoniazid.\n* Rifampin.\n* Investigational agents (unless approved by sponsor).\n* Systemic chemotherapeutic agents.\n\nPrior Medication:\n\nExcluded:\n\n* Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks.\n* Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month.\n* Systemic therapy for KS within the past month.\n\nRequired:\n\n* Antiretroviral regimen other than study drug.\n\nRequired:\n\n* Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance."}, 'identificationModule': {'nctId': 'NCT00002161', 'briefTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3', 'orgStudyIdInfo': {'id': '232C'}, 'secondaryIdInfos': [{'id': 'GS-96-408'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Adefovir dipivoxil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90509', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kraus Med Partners', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Gen Hosp', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '951282699', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa Clara Valley Med Ctr', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94403', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'San Mateo County Med Ctr / San Mateo County AIDS Prog', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Research', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor UCLA Med Ctr', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown Univ Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Institute for Clinical Research', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of South Florida', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '303081962', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Ctr for Clinical Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univ Med Ctr', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70122', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ / Tulane / LSU Clinical Trials Unit', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Univ / Massachusetts Gen Hosp', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State Univ / Univ Health Ctr', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Med College / Clinical Pharmacy Studies', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Vincent's Med Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Med Ctr', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Research and Education Group', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Univ Med Ctr', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Med Ctr', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Clinical Research Network', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Univ of Utah School of Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Univ of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}}}}