Nctid:
NCT00001471
Payload:
{"FullStudy"=>{"Rank"=>497918, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M7296", "InterventionBrowseLeafName"=>"Dimercaprol", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Prospective"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Cohort"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"635"}}, "StatusModule"=>{"OverallStatus"=>"Recruiting", "StartDateStruct"=>{"StartDate"=>"November 30, 1994", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"May 9, 2024", "LastUpdateSubmitDate"=>"May 29, 2024", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 30, 2024", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Obtain lymphoid tissue by tonsillar, lymph node, or intestinal biopsies, or BAL fluid in patients with HIV, ICL, and healthy volunteers to evaluate for viral burden, lymphocyte subsets, and cytokine production.", "PrimaryOutcomeTimeFrame"=>"Each procedure visit where tissue is obtained.", "PrimaryOutcomeDescription"=>"Evaluate for viral burden, lymphocyte subsets, and cytokine production."}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["AIDS", "HIV", "Retrovirus", "Therapy", "Response", "Natural History"]}, "ConditionList"=>{"Condition"=>["HIV", "ICL", "Healthy Volunteers"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"22241988", "ReferenceType"=>"background", "ReferenceCitation"=>"Zeng M, Southern PJ, Reilly CS, Beilman GJ, Chipman JG, Schacker TW, Haase AT. Lymphoid tissue damage in HIV-1 infection depletes naive T cells and limits T cell reconstitution after antiretroviral therapy. PLoS Pathog. 2012 Jan;8(1):e1002437. doi: 10.1371/journal.ppat.1002437. Epub 2012 Jan 5."}, {"ReferencePMID"=>"15365096", "ReferenceType"=>"background", "ReferenceCitation"=>"Brenchley JM, Schacker TW, Ruff LE, Price DA, Taylor JH, Beilman GJ, Nguyen PL, Khoruts A, Larson M, Haase AT, Douek DC. CD4+ T cell depletion during all stages of HIV disease occurs predominantly in the gastrointestinal tract. J Exp Med. 2004 Sep 20;200(6):749-59. doi: 10.1084/jem.20040874. Epub 2004 Sep 13."}, {"ReferencePMID"=>"22156200", "ReferenceType"=>"background", "ReferenceCitation"=>"Mavigner M, Cazabat M, Dubois M, L'Faqihi FE, Requena M, Pasquier C, Klopp P, Amar J, Alric L, Barange K, Vinel JP, Marchou B, Massip P, Izopet J, Delobel P. Altered CD4+ T cell homing to the gut impairs mucosal immune reconstitution in treated HIV-infected individuals. J Clin Invest. 2012 Jan;122(1):62-9. doi: 10.1172/JCI59011. Epub 2011 Dec 12."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1995-I-0027.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study will examine tissue from the tonsils, lymph nodes and large bowel of HIV-infected patients to investigate changes in viral load and certain white blood cells during treatment.\n\nNormal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly an electrocardiogram (EKG). Blood tests may include HLA typing, a genetic test of immune system markers.\n\nParticipants may undergo the following procedures:\n\nBlood tests (patients and volunteers)\nBiopsies The frequency of biopsies for given patients may vary, depending on their specific therapy. Typically, biopsies are done at a single time, or for patients starting a new therapy, biopsies could be performed before starting therapy, during therapy and possibly after completion of therapy.\nTonsil biopsies (patients and volunteers) Volunteers will have one tonsil biopsy. Patients will have no more than six tonsil biopsies, with no more than three in a 10-day period. The biopsy is done by an ear, nose and throat specialist as an outpatient procedure. The tonsils are numbed with a local anesthetic, and one to four pieces of tissue are extracted.\nLymph node biopsies (patients only) Patients will have no more than four lymph node biopsies, performed no more frequently than once a month. The biopsy is done by a surgeon and may require a 2- to 3-day hospital stay. The skin above the lymph nodes is numbed with a local anesthetic, an incision is made and the tissue is removed. Alternatively, a needle biopsy may be done, in which a small amount of lymph tissue is withdrawn through a special needle injected into the site.\nIntestinal biopsies (patients and volunteers) Volunteers will have one intestinal biopsy procedure. Patients may have up to six intestinal biopsy procedures, each separated by at least 10 days. This is done by a gastroenterologist as an outpatient procedure. A flexible tube (sigmoidoscope or colonoscope) with a light and special lens at the tip is inserted into the rectum and large bowel. Wire instruments passed through the tube are used to extract small tissue samples.\nBronchoalveolar lavage (BAL; patients and volunteers) Volunteers and patients will undergo bronchoscopy in which a flexible tube (bronchoscope) with a light and special lens at the tip is inserted through the nose or mouth into the lungs, and the lining of the lung is sampled by washing the airways with small amounts of saline. The procedure is performed by a pulmonologist or critical care specialist, usually as an outpatient.", "DetailedDescription"=>"Examining tissues outside the bloodstream in HIV-infected patients, patients with Idiopathic CD4 lymphopenia (ICL) and, for comparison, HIV-uninfected healthy volunteers (hereafter referred to as healthy volunteers), can provide insights into the pathogenesis of HIV infection and ICL. This protocol will provide a mechanism for sampling tissue sites. A total of 430 HIV-infected patients, 100 ICL patients and 105 healthy volunteers will be enrolled in these studies. To assess changes in viral load and immunological parameters at sites outside the bloodstream during therapy of HIV-infected patients, sequential tonsillar, lymph node, or intestinal biopsies, or bronchoscopy with bronchoalveolar lavage (BAL) will be undertaken during the course of therapy. In a small number of patients, sequential or simultaneous lymph node biopsies will be performed. In addition, uninfected healthy volunteers will be enrolled to have a tonsillar or intestinal biopsy, or bronchoscopy with BAL; this will allow comparison of immunologic parameters in HIVinfected and uninfected tonsillar or intestinal tissues, or BAL fluid. Finally, ICL patients may have tissue sampling to assess lymphocyte distribution and possible function in tissues to better understand the pathogenesis of their lymphopenia. Sequential or simultaneous tissue sampling may occur and longitudinal samples may also be obtained to assess stability in tissue compartments or effect of possible immunomodulatory treatments."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"100 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "SamplingMethod"=>"Non-Probability Sample", "StudyPopulation"=>"This study will include patients already seen in our outpatient clinic, as well as individuals recruited from outside clinics.", "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nGreater than or equal to 18 years old.\n\nAbility to sign informed consent.\n\nFor women of child-bearing potential, negative result on a serum or urine pregnancy test within 1 week prior to the procedure.\n\nWillingness to allow storage of blood or biopsy samples for possible future use to study HIV/AIDS, related diseases or the immune system; willingness to permit HLA testing.\n\nFOR PATIENTS UNDERGOING BIOPSIES:\n\nNo medical contraindication to tonsillar, lymph node, or intestinal biopsy.\n\nFor tonsillar biopsy, presence of visible tonsillar tissue; for lymph node biopsy, palpable lymph nodes.\n\nNo aspirin or piroxicam (Feldene) for 10 days prior to the procedure; other non steroidal anti-inflammatory drugs (e.g. ibuprofen) must be discontinued the day prior to the procedure. Acetaminophen [Tylenol] is permitted at any time.\n\nFOR PATIENTS UNDERGOING BAL:\n\nHematocrit greater than 27 percent, platelets greater than 50,000/ml.\n\nBaseline pulse-oximetry recording of 94 percent or greater unless clinical indication for bronchoscopy.\n\nNo medical contraindication to bronchoscopy.\n\nIn addition to the above:\n\nFOR HIV POSITIVE VOLUNTEERS:\n\nHIV infection must be confirmed by ELISA and western blot or dot blot. For patients with acute HIV infection and negative HIV serology, plasma HIV viral load greater than 10,000 copies/ml.\n\nFOR HEALTHY VOLUNTEERS:\n\nNo underlying significant medical problem, especially an immunodeficiency or autoimmune disease, or an underlying problem requiring immunosuppressive therapy.\n\nAbsence of HIV infection as confirmed by negative ELISA and, if indicated, western blot or dot blot.\n\nFOR ICL PATIENTS:\n\nPatients must meet the definition of ICL according to the CDC criteria: documented absolute CD4 T lymphocyte count of less than 300 cells per cubic millimeter or of less than 20 percent of total T cells on more than one occasion usually two to three months apart, without evidence of HIV infection or any defined immunodeficiency or therapy associated with depressed levels of CD4 T cells.\n\nAbsence of HIV infection as confirmed by negative ELISA and, if indicated, western blot or dot blot.\n\nEXCLUSION CRITERIA:\n\nFOR ALL VOLUNTEERS UNDERGOING BIOPSIES:\n\nPlatelet count less than 75,000 platelets/mm(3).\n\nPT or PTT prolonged by greater than 2 seconds unless patient has documented lupus anticoagulant/anti-phospholipid syndrome, which is not associated with an increased bleeding risk\n\nKnown underlying bleeding disorder.\n\nPregnancy.\n\nFOR HIV-POSITIVE OR ICL VOLUNTEERS FOR LYMPH NODE BIOPSIES:\n\nUse of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy.\n\nFOR ALL VOLUNTEERS FOR INTESTINAL BIOPSIES:\n\nUse of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy.\n\nSignificant heart valve abnormalities.\n\nPresence of pacemaker, artificial joint or vascular surgery graft.\n\nFOR ALL VOLUNTEERS FOR BAL:\n\nUse of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy.\n\nPregnancy.\n\nAny medical condition for which the investigators believe bronchoscopy may be contraindicated.\n\nAllergy to lidocaine.\n\nHistory of asthma requiring therapy."}, "IdentificationModule"=>{"NCTId"=>"NCT00001471", "BriefTitle"=>"Tissue Biopsy and Imaging Studies in HIV-Infected Patients", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Virologic and Immunologic Evaluation of Lymph Node, Tonsillar and Intestinal Biopsies, and Bronchoalveolar Lavage Fluid", "OrgStudyIdInfo"=>{"OrgStudyId"=>"950027"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"95-I-0027"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupLabel"=>"Healthy Volunteers", "ArmGroupDescription"=>"Healthy Volunteers"}, {"ArmGroupLabel"=>"HIV-infected", "ArmGroupDescription"=>"HIV-infected individuals"}, {"ArmGroupLabel"=>"ICL", "ArmGroupDescription"=>"Idiopathic CD4 lymphopenia"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationStatus"=>"Recruiting", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center", "LocationContactList"=>{"LocationContact"=>[{"LocationContactName"=>"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)", "LocationContactRole"=>"Contact", "LocationContactEMail"=>"ccopr@nih.gov", "LocationContactPhone"=>"800-411-1222", "LocationContactPhoneExt"=>"TTY dial 711"}]}}]}, "CentralContactList"=>{"CentralContact"=>[{"CentralContactName"=>"Cheryl L. Pauls", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"paulsc@nih.gov", "CentralContactPhone"=>"(301) 481-2260"}, {"CentralContactName"=>"Joseph A Kovacs, M.D.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"jkovacs@mail.nih.gov", "CentralContactPhone"=>"(301) 496-9907"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Joseph A Kovacs, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
