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The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants

Primary Purpose

HIV Infections

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anti-HIV Immune Serum Globulin (Human)
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine

Eligibility Criteria

1 Day - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Recommended: Standard immunizations. Should repeat MMR 3 months after discontinuing study. Benadryl and/or aspirin. Pneumocystis carinii pneumonia prophylaxis. Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy. Aerosol ribavirin for short-term treatment of RSV. Concurrent Treatment: Allowed: Blood transfusion. Patients must have the following: Parent or guardian available to give written informed consent. Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study. Prior Medication: Allowed: Gammaglobulin, intravenous (IV) or intramuscular (IM). Immunoglobulin, IV (IVIG). Maternal antiretroviral treatment during pregnancy. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. Presence of serious acute infection requiring parenteral treatment at time of study entry. Concurrent Medication: Excluded: Prophylaxis for oral candidiasis or otitis media or other infections. Immunoglobulin therapy (except single dose or for hypogammaglobulinemia). Ketoconazole, acyclovir, or nystatin for prophylaxis. Patients with the following are excluded: Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. Presence of serious acute infection requiring parenteral treatment at time of study entry. Prior Medication: Excluded: Antiretroviral treatment or experimental treatment within 2 weeks of entry.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    October 28, 2021
    Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
    Collaborators
    Abbott, Glaxo Wellcome
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000961
    Brief Title
    The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
    Official Title
    A Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Terminated
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    May 1991 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
    Collaborators
    Abbott, Glaxo Wellcome

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the safety and tolerance of hyperimmune anti-HIV intravenous immunoglobulin (HIVIG) and of zidovudine (AZT) in infants with established HIV infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in HIV infected infants. HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease.
    Detailed Description
    HIVIG may be an effective agent that either alone or in combination with AZT will prevent progression of clinical disease. Participants are randomized to receive either oral AZT or HIVIG. Patients may receive treatment for a maximum of 48 weeks. Patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. Infants who are receiving HIVIG initially are treated with the appropriate age-adjusted dose of oral AZT in addition to HIVIG if they meet clinical disease progression criteria. All participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. This follow-up may be conducted over the telephone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Drug Therapy, Combination, Zidovudine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Enrollment
    112 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Anti-HIV Immune Serum Globulin (Human)
    Intervention Type
    Drug
    Intervention Name(s)
    Zidovudine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Concurrent Medication: Allowed: Recommended: Standard immunizations. Should repeat MMR 3 months after discontinuing study. Benadryl and/or aspirin. Pneumocystis carinii pneumonia prophylaxis. Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy. Aerosol ribavirin for short-term treatment of RSV. Concurrent Treatment: Allowed: Blood transfusion. Patients must have the following: Parent or guardian available to give written informed consent. Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study. Prior Medication: Allowed: Gammaglobulin, intravenous (IV) or intramuscular (IM). Immunoglobulin, IV (IVIG). Maternal antiretroviral treatment during pregnancy. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. Presence of serious acute infection requiring parenteral treatment at time of study entry. Concurrent Medication: Excluded: Prophylaxis for oral candidiasis or otitis media or other infections. Immunoglobulin therapy (except single dose or for hypogammaglobulinemia). Ketoconazole, acyclovir, or nystatin for prophylaxis. Patients with the following are excluded: Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry. Presence of serious acute infection requiring parenteral treatment at time of study entry. Prior Medication: Excluded: Antiretroviral treatment or experimental treatment within 2 weeks of entry.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Connor E
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7935655
    Citation
    Spector SA, Gelber RD, McGrath N, Wara D, Barzilai A, Abrams E, Bryson YJ, Dankner WM, Livingston RA, Connor EM. A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. Pediatric AIDS Clinical Trials Group. N Engl J Med. 1994 Nov 3;331(18):1181-7. doi: 10.1056/NEJM199411033311802.
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    The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants

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