The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children

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

Nctid: NCT00000983

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{"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000019380", "InterventionAncestorTerm"=>"Anti-HIV Agents"}, {"InterventionAncestorId"=>"D000044966", "InterventionAncestorTerm"=>"Anti-Retroviral Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M17610", "InterventionBrowseLeafName"=>"Zidovudine", "InterventionBrowseLeafAsFound"=>"Extremity", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20625", "InterventionBrowseLeafName"=>"Reverse Transcriptase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", 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"DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"400"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"December 1994", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 28, 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"=>["Acquired Immunodeficiency Syndrome", "Zidovudine"]}, "ConditionList"=>{"Condition"=>["HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"9041402", "ReferenceType"=>"background", "ReferenceCitation"=>"Lathey JL, Marschner IC, Kabat B, Spector SA. Deterioration of detectable human immunodeficiency virus serum p24 antigen in samples stored for batch testing. J Clin Microbiol. 1997 Mar;35(3):631-5. doi: 10.1128/jcm.35.3.631-635.1997."}, {"ReferencePMID"=>"7699053", "ReferenceType"=>"background", "ReferenceCitation"=>"Fiscus SA, Welles SL, Spector SA, Lathey JL. Length of incubation time for human immunodeficiency virus cultures. J Clin Microbiol. 1995 Jan;33(1):246-7. doi: 10.1128/jcm.33.1.246-247.1995."}, {"ReferencePMID"=>"8627060", "ReferenceType"=>"background", "ReferenceCitation"=>"Brady MT, McGrath N, Brouwers P, Gelber R, Fowler MG, Yogev R, Hutton N, Bryson YJ, Mitchell CD, Fikrig S, Borkowsky W, Jimenez E, McSherry G, Rubinstein A, Wilfert CM, McIntosh K, Elkins MM, Weintrub PS. Randomized study of the tolerance and efficacy of high- versus low-dose zidovudine in human immunodeficiency virus-infected children with mild to moderate symptoms (AIDS Clinical Trials Group 128). Pediatric AIDS Clinical Trials Group. J Infect Dis. 1996 May;173(5):1097-106. doi: 10.1093/infdis/173.5.1097."}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Brady M, McGrath N, Brouwers P, Gelber R, Fowler M, Weintrub P. Controlled trial of tolerance and efficacy of zidovudine (ZDV) at standard and low dose in children (ACTG 128). The Pediatric AIDS Clinical Trials Group. Int Conf AIDS. 1994 Aug 7-12;10(1):79 (abstract no 268B)"}, {"ReferenceType"=>"background", "ReferenceCitation"=>"Parent D, Ellner J, Hafner R, Williams M, Jacobs P, Hojczyk P. A phase II/III trial of Rifampin (RIF) Ciprofloxach (CIPRO), Clofazimine (CLOF), Ethambutol (ETH), +/- Amikacin (AK) in the treatment (RX) of Disseminated Mycobacterium avium (MA) infection in HIV-infected individuals (PTS). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:56"}, {"ReferencePMID"=>"21037891", "ReferenceType"=>"background", "ReferenceCitation"=>"Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To evaluate and compare differences in tolerance and side effects associated with two different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are differences in the rate and degree of toxicities associated with one versus the other dosage.\n\nAZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.", "DetailedDescription"=>"AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.\n\nAll participants are randomized to receive AZT at 1 of 2 doses. Patients are stratified according to whether CD4 cell counts are > or < 500 cells/mm3 as well as whether symptoms are mild to moderate or if patients have lymphocytic interstitial pneumonitis (LIP). Medication is dispensed every other week for the first 8 weeks and monthly until week 104, then either monthly or every 3 months. Safety and effectiveness of the treatment program are evaluated at 6-month intervals to assess whether it is appropriate to continue the study as originally designed. Patients are evaluated every 2 weeks for the first 8 weeks, monthly until week 104, every 3 months until week 208, and then every 6 months thereafter."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"12 years", "MinimumAge"=>"3 months", "StdAgeList"=>{"StdAge"=>["Child"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAMENDED:\n\n03-19-91 Prophylaxis for PCP is recommended according to current practice guidelines. As per published recommendations, primary prophylaxis with TMP / SMX on a M-T-W basis is encouraged.\n\nAllowed:\n\nImmunoglobulin therapy as single dose exposure prophylaxis or for children with hypogammaglobulinemia.\nTrimethoprim / sulfamethoxazole (TMP / SMX) and parenteral or aerosolized pentamidine for prophylaxis for Pneumocystis carinii pneumonia for children with AIDS and/or CD4+ counts = or < 500 cells/mm3.\nSystemic ketoconazole and acyclovir, or oral nystatin for acute therapy.\nAerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV).\n\nAMENDED:\n\n9/17/90 enrollment is limited to children < 6 years of age.\nOriginal design:\nPatients must have the following:\nParent or guardian available to give written informed consent.\nLaboratory evidence of HIV infection.\nChildren < 15 months of age, with CD4+ cell count > 500 cells/mm3, who are thought to have acquired HIV through perinatal transmission and whose only laboratory evidence of HIV infection is a positive antibody test, must also have one or more of the laboratory criteria described in Disease Status AND one or more of the disease criteria that are required of children > 15 months old with CD4+ cell counts > 500 cells/mm3.\n\nPrior Medication:\n\nAllowed:\n\nAerosol ribavirin.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\nPrevious AIDS-defining opportunistic infection or neoplasms as specified by the CDC surveillance criteria for AIDS.\n\nPrevious unexplained recurrent, serious bacterial infections (two or more within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria.\nQualifying for entrance criteria to zidovudine (AZT) + or - gammaglobulin (ACTG 051).\nEncephalopathy.\nFailure to thrive (defined as a child who crosses two percentile lines on the growth chart or child who is < fifth percentile and does not follow curve) and/or oral candidiasis for at least 2 months despite appropriate topical therapy.\nLymphocytic interstitial pneumonitis (LIP) with steroid dependency or requiring supplemental oxygen.\nPreexisting malignancies.\n\nConcurrent Medication:\n\nAMENDED:\n\n03-19-91 Prophylaxis with antiviral or antifungals agents, except for PCP prophylaxis is prohibited.\nDrugs that are metabolized by hepatic glucuronidation should be used with caution.\n\nExcluded:\n\nProphylaxis for oral candidiasis or otitis media or other infections (sinusitis, urinary tract infections).\nImmunoglobulin therapy not specifically allowed.\nKetoconazole, acyclovir, or nystatin for prophylaxis.\nDrugs that are metabolized by hepatic glucuronidation and might alter metabolism of zidovudine (AZT).\n\nPatients with the following are excluded:\n\nPrevious AIDS-defining opportunistic infection or neoplasms as specified by the CDC surveillance criteria for AIDS.\nPrevious unexplained recurrent, serious bacterial infections (two or more within a 2-year period) including sepsis, meningitis, pneumonia, abscess of an internal organ, and bone/joint infections caused by Haemophilus, Streptococcus, or other pyogenic bacteria.\nQualifying for entrance criteria to zidovudine (AZT) + or - gammaglobulin (ACTG 051).\nEncephalopathy.\nFailure to thrive (defined as a child who crosses two percentile lines on the growth chart or child who is < fifth percentile and does not follow curve) and/or oral candidiasis for at least 2 months despite appropriate topical therapy.\nLymphocytic interstitial pneumonitis (LIP) with steroid dependency or requiring supplemental oxygen.\nPreexisting malignancies.\n\nPrior Medication:\n\nExcluded within 2 weeks of study entry:\n\nAny other experimental therapy or drugs that cause prolonged neutropenia or significant nephrotoxicity.\n\nExcluded within 1 month of study entry:\n\nAntiretroviral agents.\nImmunomodulating agents including immunoglobulin, interferon, isoprinosine, and IL-2.\n\nExcluded within 2 months of study entry:\n\nSystemic ribavirin for retroviral therapy.\n\nPrior Treatment:\n\nExcluded within 1 month of study entry:\n\nLymphocyte or red blood cell transfusions.\n\nActive alcohol or drug abuse."}, "IdentificationModule"=>{"NCTId"=>"NCT00000983", "BriefTitle"=>"The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Randomized Blinded Trial To Evaluate the Safety and Tolerance of High Versus Low Dose Zidovudine Administered to Children With Human Immunodeficiency Virus", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 128"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11103", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Zidovudine", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"902422814", "LocationCity"=>"Downey", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Kaiser Permanente / UCLA Med Ctr"}, {"LocationZip"=>"90801", "LocationCity"=>"Long Beach", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Long Beach Memorial (Pediatric)"}, {"LocationZip"=>"900276016", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Children's Hosp of Los Angeles/UCLA Med Ctr"}, {"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Los Angeles County - 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