A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus
      intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by
      1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection
      in children is most often associated with symptomatic disease and poor prognosis. Treatment
      with antiviral therapy may be effective in changing the course of disease and decreasing
      mortality in this vulnerable population. AZT treatment has been shown to decrease mortality
      and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it
      is likely that children may also benefit from this antiviral therapy. In addition, bacterial
      infections are frequently found in HIV-infected children. Because pooled human serum
      immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in
      patients with defects of immunity, it may reduce the rate of bacterial infection in
      HIV-infected children as well. In this study, AZT will be administered together with IVIG to
      determine safety, tolerance, and efficacy of the combined treatment.
    

Detailed description: 
      It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the
      United States. HIV infection in children is most often associated with symptomatic disease
      and poor prognosis. Treatment with antiviral therapy may be effective in changing the course
      of disease and decreasing mortality in this vulnerable population. AZT treatment has been
      shown to decrease mortality and the frequency of opportunistic infections in certain adult
      AIDS patients; therefore, it is likely that children may also benefit from this antiviral
      therapy. In addition, bacterial infections are frequently found in HIV-infected children.
      Because pooled human serum immunoglobulin, another name for antibodies, is effective in
      reducing bacterial infection in patients with defects of immunity, it may reduce the rate of
      bacterial infection in HIV-infected children as well. In this study, AZT will be administered
      together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.

      The study includes 250 children, 3 months to 12 years of age. All participants receive oral
      AZT. IVIG or intravenous placebo is administered every 28 days. Patients are followed for the
      development of serious bacterial infection, as well as for a number of factors relating to
      safety, tolerance, progression of disease, and survival. This is an outpatient study
      conducted over a minimum 100-week period. The children are evaluated every 2 weeks for the
      first 8 weeks, and monthly thereafter.
    

Intervention name(s): Globulin, Immune; Zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Immunoglobulins; Antibodies
Masking: Double
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Placebos; Infusions, Intravenous; Gamma-Globulins; Combined Modality Therapy; Acquired Immunodeficiency Syndrome; Zidovudine; Bacterial Infections; Immunization, Passive