Nctid:
NCT00001063
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000015215", "term"=>"Zidovudine"}, {"id"=>"D000018119", "term"=>"Stavudine"}, {"id"=>"D000016049", "term"=>"Didanosine"}], "ancestors"=>[{"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D000044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Tract", "relevance"=>"HIGH"}, {"id"=>"M20272", "name"=>"Stavudine", "asFound"=>"/hour", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Catheter ablation", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"1997-11", "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"=>["Didanosine", "Drug Therapy, Combination", "AIDS-Related Complex", "Zidovudine", "Stavudine"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11364024", "type"=>"BACKGROUND", "citation"=>"d4T+AZT--unexpected CD4 drop seen in study. AIDS Treat News. 1996 Dec 20;(No 261):1."}, {"type"=>"BACKGROUND", "citation"=>"Shaefer M, Hardy WD, Shaker-Irwin L, Williams V, Maude C, Thommes J, Graham N. HIV viral load response in subjects switched from zidovudine (ZDV)-containing to stavudine (D4T)-containing regimens in the Pacific Oaks Population Study (POPS). Int Conf AIDS. 1998;12:57 (abstract no 12228)"}, {"type"=>"BACKGROUND", "citation"=>"Havlir DV, Friedland G, Pollard R, Tierney C, Smeaton L, Fox L, Richman DD. Combination zidovudine (ZDV) and stavudine (d4T) therapy versus other nucleosides: report of two randomized trials (ACTG 290 and 298). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 2)"}, {"pmid"=>"11365218", "type"=>"BACKGROUND", "citation"=>"Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8."}, {"pmid"=>"10882616", "type"=>"BACKGROUND", "citation"=>"Havlir DV, Tierney C, Friedland GH, Pollard RB, Smeaton L, Sommadossi JP, Fox L, Kessler H, Fife KH, Richman DD. In vivo antagonism with zidovudine plus stavudine combination therapy. J Infect Dis. 2000 Jul;182(1):321-5. doi: 10.1086/315683. Epub 2000 Jul 6."}, {"type"=>"BACKGROUND", "citation"=>"Sommadossi JP, Zhou XJ, Moore J, Havlir DV, Friedland G, Tierney C, Smeaton L, Fox L, Richman D, Pollard R. Impairment of stavudine (d4T) phosphorylation in patients receiving a combination of zidovudine (ZDV) and d4T (ACTG 290). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 3)"}]}, "descriptionModule"=>{"briefSummary"=>"To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected patients \\[AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone versus AZT plus ddI\\]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular level.\n\nAlthough AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count.", "detailedDescription"=>"Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count.\n\nPatients are randomized in a blinded fashion to receive AZT or placebo in combination with open-label d4T or ddI for up to 48 weeks. AS PER AMENDMENT 3/21/97: The study is now composed of three arms: open-label d4T versus open-label ddI plus blinded AZT placebo versus blinded AZT plus open-label ddI. Patients originally assigned to the d4T + AZT arm, which was closed 10/96, will be given the option of discontinuing AZT and remaining on d4T monotherapy or discontinuing all study drugs. In addition, all study participants will be asked to participate in a pharmacology substudy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired for patients whose CD4 count falls below 200 cells/mm3:\n\n* PCP prophylaxis with TMP/SMX, aerosolized pentamidine, or dapsone.\n\nAllowed:\n\n* Atovaquone, IV pentamidine, trimethoprim-dapsone, clindamycin-primaquine, trimetrexate, or TMP/SMX for acute PCP.\n* Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for mucosal and esophageal candidiasis.\n* Itraconazole.\n* Amphotericin B.\n* Rifabutin.\n* Isoniazid.\n* Pyrazinamide.\n* Clofazimine.\n* Clarithromycin.\n* Azithromycin.\n* Ethambutol.\n* Amikacin.\n* Ciprofloxacin.\n* Ofloxacin.\n* Pyrimethamine.\n* Sulfadiazine.\n* Clindamycin.\n* Ganciclovir.\n* G-CSF.\n* Acyclovir (up to 1000 mg/day).\n* Erythropoietin.\n* Antibiotics for bacterial infections.\n* Antipyretics.\n* Analgesics.\n* Antiemetics.\n* Rifampin.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Local radiation therapy.\n\nPatients must have:\n\n* HIV infection.\n* CD4 count 300-600 cells/mm3.\n* More than 12 weeks (was 24 weeks, AMENDED 3/31/96) of total prior AZT ( \\> 500 mg/day without serious adverse event). Subjects must be actively taking ZDV for at least 4 continuous weeks up to the time of study entry.\n* No prior or current history of AIDS.\n* No active opportunistic infection.\n* Life expectancy of at least 2 years.\n* Consent of patient and parent or guardian if less than 18 years of age.\n\nNOTE:\n\n* Protocol is approved for prisoner enrollment.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Malignancy requiring systemic cytotoxic chemotherapy.\n* Serious underlying medical condition other than HIV that would reduce life expectancy to \\< 2 years.\n\nConcurrent Medication:\n\nExcluded:\n\n* Antiretrovirals other than study drugs.\n* Foscarnet.\n\nPatients with the following prior conditions are excluded:\n\n* Unexplained temperature \\>= 38.5 C for 7 days or chronic diarrhea (\\>= three stools daily) for 15 days, if occurring within 30 days prior to study entry.\n* History of acute or chronic pancreatitis.\n* History of grade 2 or higher peripheral neuropathy.\n* History of grade 3 or worse intolerance to 500-600 mg/day AZT.\n\nPrior Medication:\n\nExcluded:\n\n(within 30 days prior to study entry)\n\n* Prior ddI, ddC, 3TC or d4T (more than 2 weeks total).\n* Non-nucleoside reverse transcriptase inhibitor or protease inhibitor.\n* Biologic response modifiers such as interferon and IL-2.\n* Other experimental therapy."}, "identificationModule"=>{"nctId"=>"NCT00001063", "briefTitle"=>"The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Phase II Randomized Study of the Virologic and Immunologic Effects of d4T vs Zidovudine Plus d4T vs Zidovudine Plus Ddl in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and Greater Than 12 Weeks Zidovudine Experience", "orgStudyIdInfo"=>{"id"=>"ACTG 290"}, "secondaryIdInfos"=>[{"id"=>"11266", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Stavudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Center CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94115", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Stanford CRS", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"92103", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"Ucsd, Avrc Crs", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Ucsf Aids Crs", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"90502", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor-UCLA Med. Ctr. CRS", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"80262", "city"=>"Aurora", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Hospital CRS", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}, {"zip"=>"20010", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Children's National Med. Ctr., ACTU", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"32209", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Florida Jacksonville NICHD CRS", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ. of Miami AIDS CRS", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Univ. of Hawaii at Manoa, Leahi Hosp.", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern University CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Cook County Hosp. CORE Ctr.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Univ. Med. Ctr. ACTG CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Weiss Memorial Hosp.", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Wishard Memorial", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Methodist Hosp. of Indiana", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Hemophilia Treatment Ctr.", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts General Hospital ACTG CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Bmc Actg Crs", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess Med. Ctr., ACTG CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"55415", "city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"Hennepin County Med. Ctr., Div. of Infectious Diseases", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"University of Minnesota, ACTU", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"zip"=>"63112", "city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"St. Louis ConnectCare, Infectious Diseases Clinic", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington U CRS", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"14215", "city"=>"Buffalo", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY - Buffalo, Erie County Medical Ctr.", "geoPoint"=>{"lat"=>42.88645, "lon"=>-78.87837}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ. of Rochester ACTG CRS", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ. of Cincinnati CRS", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"The Ohio State Univ. AIDS CRS", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"98122", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"University of Washington AIDS CRS", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"00936", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp. PR NICHD CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Puerto Rico-AIDS CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Havlir D", "role"=>"STUDY_CHAIR"}, {"name"=>"Richman D", "role"=>"STUDY_CHAIR"}, {"name"=>"Pollard R", "role"=>"STUDY_CHAIR"}, {"name"=>"Friedland G", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}