A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Nctid: NCT00000841

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"LastUpdateSubmitDate"=>"October 27, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 4, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "Antiviral Agents", "Zidovudine", "Stavudine", "HIV Protease Inhibitors", "Lamivudine", "Indinavir"]}, "ConditionList"=>{"Condition"=>["HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Reiter G, Wojnarowski C. Low rate of nelfinavir discontinuation in a clinic population. Int Conf AIDS. 1998;12:1049 (abstract no 60273)"}, {"ReferencePMID"=>"11361796", "ReferenceType"=>"background", "ReferenceCitation"=>"ACTG 320 trial halted as three-drug arm proves superior. AIDS Patient Care STDS. 1997 Jun;11(3):194. No abstract available."}, {"ReferencePMID"=>"11364769", "ReferenceType"=>"background", "ReferenceCitation"=>"Conference updates show promising drug data. AIDS Alert. 1997 Nov;12(11):125-6."}, {"ReferencePMID"=>"11364527", "ReferenceType"=>"background", "ReferenceCitation"=>"Baker R. 3-drug therapy reduces deaths and new AIDS-related illnesses by 50%. BETA. 1997 Mar:3-4."}, {"ReferencePMID"=>"11730396", "ReferenceType"=>"background", "ReferenceCitation"=>"Demeter LM, Hughes MD, Coombs RW, Jackson JB, Grimes JM, Bosch RJ, Fiscus SA, Spector SA, Squires KE, Fischl MA, Hammer SM. Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320. Ann Intern Med. 2001 Dec 4;135(11):954-64. doi: 10.7326/0003-4819-135-11-200112040-00007."}, {"ReferencePMID"=>"12037070", "ReferenceType"=>"background", "ReferenceCitation"=>"Demeter LM, Bosch RJ, Coombs RW, Fiscus S, Bremer J, Johnson VA, Erice A, Jackson JB, Spector SA, Squires KM, Fischl MA, Hughes MD, Hammer SM. Detection of replication-competent human immunodeficiency virus type 1 (HIV-1) in cultures from patients with levels of HIV-1 RNA in plasma suppressed to less than 500 or 50 copies per milliliter. J Clin Microbiol. 2002 Jun;40(6):2089-94. doi: 10.1128/JCM.40.6.2089-2094.2002."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Coplan P, Cook J, Carides G, Nguyen BY, Testa M. Impact of indinavir with zidovudine and lamivudine on quality of life for HIV patients with < or = 200 CD4 in ACTG 320. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:86 (abstract no 101)"}, {"ReferencePMID"=>"9287227", "ReferenceType"=>"background", "ReferenceCitation"=>"Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ Jr, Feinberg JE, Balfour HH Jr, Deyton LR, Chodakewitz JA, Fischl MA. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med. 1997 Sep 11;337(11):725-33. doi: 10.1056/NEJM199709113371101."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Demeter LM, Degruttola V, Eshleman S, Jackson JB, Hughes M, Hammer SM. Baseline (BL) HIV-1 protease (PR) and reverse transcriptase (RT) genotype as a predictor of response to ZDV+3TC+indinavir (IDV). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:92 (abstract no 131)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Freedberg KA, Goldie SJ, Paltiel AD, Losina E, Cohen CJ, Seage GR, Craven DE, Zhang H, Kimmel AD, Sullivan LM, Weinstein MC. Combination antiretroviral therapy is both effective and cost-effective. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29 (abstract no I-2070)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Levine, AM. HPV Infection and Cervical/Anal Precursor Lesions in the HAART Era. http://www.medscape.com/viewarticle/440151"}, {"ReferencePMID"=>"15307012", "ReferenceType"=>"background", "ReferenceCitation"=>"Coplan PM, Cook JR, Carides GW, Heyse JF, Wu AW, Hammer SM, Nguyen BY, Meibohm AR, DiNubile MJ; AIDS Clinical Trials Group 320 Study Team. Impact of indinavir on the quality of life in patients with advanced HIV infection treated with zidovudine and lamivudine. Clin Infect Dis. 2004 Aug 1;39(3):426-33. doi: 10.1086/422520. Epub 2004 Jul 19."}, {"ReferencePMID"=>"15892437", "ReferenceType"=>"result", "ReferenceCitation"=>"Mrus JM, Williams PL, Tsevat J, Cohn SE, Wu AW. Gender differences in health-related quality of life in patients with HIV/AIDS. Qual Life Res. 2005 Mar;14(2):479-91. doi: 10.1007/s11136-004-4693-z."}, {"ReferencePMID"=>"16547789", "ReferenceType"=>"result", "ReferenceCitation"=>"Mrus JM, Schackman BR, Wu AW, Freedberg KA, Tsevat J, Yi MS, Zackin R. Variations in self-rated health among patients with HIV infection. Qual Life Res. 2006 Apr;15(3):503-14. doi: 10.1007/s11136-005-1946-4."}, {"ReferencePMID"=>"20547574", "ReferenceType"=>"result", "ReferenceCitation"=>"Cole SR, Stuart EA. Generalizing evidence from randomized clinical trials to target populations: The ACTG 320 trial. Am J Epidemiol. 2010 Jul 1;172(1):107-15. doi: 10.1093/aje/kwq084. Epub 2010 Jun 14."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients.\n\nProtease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.", "DetailedDescription"=>"Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.\n\nPatients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks. Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine ( d4T ) for AZT. Patients are followed at weeks 4, 8, 16, 24, 32, 40, and 48 and every 8 weeks thereafter up to week 96. [AS PER 02/25/97 AMENDMENT: Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy. An open label extension phase has been added for the period through 06/30/97. Patients who had been randomized to AZT/3TC are given the option of continuing on assigned ACTG 320 study drugs, crossing over to open-label indinavir, or permanently discontinuing all study therapies and going off study. Patients who were randomized to AZT/3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies. It is strongly suggested that patients who were on AZT/3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible.] [ AS PER 06/06/97 AMENDMENT: The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks (but not beyond 09/30/97). This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual (the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized).] [ AS PER 09/15/97 AMENDMENT: Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372.]"}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nRequired:\n\nPCP prophylaxis.\n\nAllowed:\n\nTopical or oral antifungal agents (other than oral ketoconazole).\nApproved agents for opportunistic infections.\nAntibiotics unless specifically excluded.\nSystemic corticosteroids for no more than 21 days.\nVitamins.\nRecombinant erythropoietin.\nG-CSF.\nRegularly prescribed medications such as allergy medications, antidepressants, antipyretics, analgesics, oral contraceptives, megestrol, and testosterone.\n\nConcurrent Treatment:\n\nAllowed:\n\nAcupuncture.\nVisualization techniques.\n\nPatients must have:\n\nHIV infection.\nCD4 count <= 200 cells/mm3.\nAt least 6 months total prior AZT therapy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nMalignancy requiring systemic therapy other than minimal Kaposi's sarcoma.\n\nConcurrent Medication:\n\nExcluded:\n\nAntiretrovirals other than study drugs.\nRifabutin and rifampin.\nInvestigational drugs other than indinavir sulfate.\nSystemic cytotoxic chemotherapy.\nOral ketoconazole.\nChronic systemic corticosteroids.\nHerbal therapies.\n\nPatients with the following prior conditions are excluded:\n\nUnexplained temperature > 38.5 C for any 7 days within 30 days prior to study entry.\nChronic diarrhea persisting for 15 days within 30 days prior to study entry.\nHistory of acute or chronic pancreatitis.\nAcute hepatitis within 30 days prior to study entry.\nGrade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry.\nDose-limiting intolerance to prior AZT at 600 mg/day.\n\nPrior Medication:\n\nExcluded:\n\nMore than 1 week of prior 3TC.\nAny prior protease inhibitors.\nRifampin or rifabutin within 14 days prior to study entry.\n\nExcluded within 30 days prior to study entry:\n\nErythropoietin.\nG-CSF or GM-CSF.\nNon-nucleoside reverse transcriptase inhibitors.\nInterferons.\nInterleukins.\nHIV vaccines.\nAny experimental therapy."}, "IdentificationModule"=>{"NCTId"=>"NCT00000841", "BriefTitle"=>"A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 320"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11294", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Indinavir sulfate", "InterventionType"=>"Drug"}, {"InterventionName"=>"Lamivudine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Stavudine", "InterventionType"=>"Drug"}, {"InterventionName"=>"Zidovudine", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"35294", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Alabama at Birmingham"}, {"LocationZip"=>"90027", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp of Los Angeles"}, {"LocationZip"=>"900331079", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Southern California / LA County USC Med Ctr"}, {"LocationZip"=>"90095", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA CARE Ctr"}, {"LocationZip"=>"921036325", "LocationCity"=>"San Diego", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of California / San Diego Treatment Ctr"}, {"LocationZip"=>"941102859", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"San Francisco AIDS Clinic / San Francisco Gen Hosp"}, {"LocationZip"=>"941102859", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"San Francisco Gen Hosp"}, {"LocationZip"=>"94115", "LocationCity"=>"San Francisco", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Stanford at Kaiser / Kaiser Permanente Med Ctr"}, {"LocationZip"=>"943055107", "LocationCity"=>"Stanford", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"San Mateo AIDS Program / Stanford Univ"}, {"LocationZip"=>"943055107", "LocationCity"=>"Stanford", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Stanford Univ Med Ctr"}, {"LocationZip"=>"90502", "LocationCity"=>"Torrance", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Harbor UCLA Med Ctr"}, {"LocationZip"=>"80262", "LocationCity"=>"Denver", "LocationState"=>"Colorado", "LocationCountry"=>"United States", "LocationFacility"=>"Kaiser Permanente Franklin Med Ctr"}, {"LocationZip"=>"80262", 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