The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children With Mild to Moderate Symptoms
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety and usefulness of zidovudine (AZT) for the treatment of children 3
      months to 12 years of age. This study is designed to determine if children who are infected
      with HIV and who have a special type of lung disease called lymphocytic interstitial
      pneumonitis (LIP) or other early symptoms of HIV infection may derive benefit from treatment
      with AZT. It is hoped that this drug will prevent children from developing additional
      symptoms and infections and will help resolve already existing symptoms.

      AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been
      shown to decrease the mortality and the frequency of opportunistic infections in certain
      adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic
      HIV-infected children may also benefit from specific antiviral therapy.
    

Detailed description: 
      AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been
      shown to decrease the mortality and the frequency of opportunistic infections in certain
      adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic
      HIV-infected children may also benefit from specific antiviral therapy.

      Children who participate in the study are evaluated at a hospital outpatient clinic and are
      under the care of a specialist in pediatrics. Of the children who participate in the study,
      half receive AZT syrup and half receive a placebo (sugar solution). The investigator does not
      know which medication each child receives as this is decided by a random process. The
      children take the medication in a strawberry-flavored clear syrup every 6 hours (4 times a
      day), for a period of 2 years or 104 weeks. The children are monitored on an outpatient basis
      while receiving therapy and the tests performed on admission to the study are repeated
      several times during treatment. Blood samples are obtained once a week for the first 4 weeks,
      every other week for the next 4 weeks, and then monthly until the end of the study. At
      certain sites, Cerebrospinal fluid (CSF) is collected by lumbar puncture every 52 weeks to
      evaluate infection involving the brain and nervous system. An independent committee reviews
      the data collected on the children every 6 months. The drug is stopped or the dose reduced if
      unacceptable side effects develop. AMENDED: As of August 7, 1989 the study blind was broken,
      the placebo arm discontinued and the study closed to accrual as of September 25, 1989. The 6
      children enrolled in the study have been offered AZT.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Masking: Double
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Pulmonary Fibrosis; Zidovudine