Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-29 @ 11:16 PM
Study NCT ID:
NCT00040157
Status:
TERMINATED
Last Update Posted:
2015-12-30
First Post:
2002-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
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': 'C099405', 'term': 'dexelvucitabine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'whyStopped': 'Safety concerns', 'overallStatus': 'TERMINATED', 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2002-06-21', 'studyFirstSubmitQcDate': '2002-06-24', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['treatment experienced,', 'Stable triple anti-retroviral combination therapy in HIV-infected,', 'Achillion'], 'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.achillion.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks)\n* Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen\n* Plasma HIV RNA level \\> 1000 and \\< 30,000 copies/mL on two occasions\n* Genotypically documented M184V variant of HIV RT\n* Clinically stable HIV status with no AIDS-defining events\n* CD4 \\> 200 cells/mm3\n* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)\n* All women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of b-HCG) within 72 hours prior to the start of study medication\n* No active opportunistic infection requiring treatment\n* Subject must be able to provide written informed consent\n* Baseline laboratory values measured within 28 days of initiating study drug as follows:\n* HGB≥9.0g/dl or HCT≥27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks\n* Absolute neutrophil count≥1000 cells/mm(\\^3) (in the absence of on-going G-CSF therapy\n* Platelet count ≥75,000/mm(\\^3)\n* AST \\<7.0 times the upper limit of normal\n* ALT ,7.0 times the upper limit of normal\n* Serum creatinine \\<1.1 times the upper limit of normal\n\nExclusion Criteria\n\n* Evidence of active HBV infection as demonstrated by HBsAg positivity\n* Hepatitis C co-infection\n* Concurrent systemic antiviral treatment\n* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.\n* Alcohol abuse\n* Pregnancy or breast-feeding\n* Inability to tolerate oral medication\n* AST \\> 7.0 times the upper limit of normal\n* ALT \\> 7.0 times the upper limit of normal\n* Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.\n* Use of any other drug or substance with anti-HBV activity'}, 'identificationModule': {'nctId': 'NCT00040157', 'briefTitle': 'Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2 Trial of 4 Weeks of ACH-126,443 in Comparison With Continued Lamivudine in Stable Triple Antiretroviral Combination Therapy in HIV-Infected Subjects With Modestly Detectable Viral Load', 'orgStudyIdInfo': {'id': 'ACH443-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ACH126-443 (Beta-L-Fd4C)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Body Positive, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Horizon Medical Group, Inc.', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33306', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Community Health Care Center One, Inc.', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33160', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'South Shore Hospital', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'St. Lukes Roosevelt Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794-8153', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Infectious Disease, Dept. of Medicine', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23666', 'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Road Medical Specialists', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}}}}