A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
- Conditions
- HIV Infections
- Registration Number
- NCT00000720
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Kaiser Permanente / UCLA Med Ctr
🇺🇸Downey, California, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Martin Luther King Jr Gen Hosp / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Stanford Univ School of Medicine
🇺🇸Menlo Park, California, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Scroll for more (41 remaining)Kaiser Permanente / UCLA Med Ctr🇺🇸Downey, California, United States