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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000720 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Globulin, Immune Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine |
| Estimated Enrollment: | 250 |
| Primary Completion Date: | April 1993 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 3 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Children must have one or more of the indicator diseases of AIDS; however, there must be an absence of acute opportunistic infection and an absence of bacterial infection requiring treatment at the time of entry into the study.
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following will be excluded:
Concurrent Medication:
Excluded:
Patients with the following will be excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Active alcohol or drug abuse.
Contacts and Locations
Show 51 Study Locations| Study Chair: | Spector, SA |
More Information
| ClinicalTrials.gov Identifier: | NCT00000720 History of Changes |
| Other Study ID Numbers: | ACTG 051 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 11, 2011 |
| Health Authority: | United States: Federal Government |
|
AIDS-Related Opportunistic Infections Placebos Infusions, Intravenous Gamma-Globulins Combined Modality Therapy |
Acquired Immunodeficiency Syndrome Zidovudine Bacterial Infections Immunization, Passive |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Gamma-Globulins Antibodies Immunoglobulins |
Zidovudine Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |