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A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine Clinical research trials and A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine. A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine clinical trial. Subjects often receive the most expert healthcare possible for their A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine  A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Benadryl and/or acetaminophen may be given before and during intravenous immunoglobulin (IVIG) infusion in patients demonstrating mild reactions during infusion. - Acetaminophen for short-term fever and pain. - Zidovudine (AZT). - Steroids. - Oral or systemic (swish and swallow) nystatin. - Maintenance therapy for fungal disease or tuberculosis. - Prophylaxis for a previous episode of Pneumocystis carinii pneumonia (PCP) including the use of trimethoprim / sulfamethoxazole (TMP / SMX). The dosage is specified as TMP 75 mg/m2 twice daily 3 times a week and SMX 375 mg/m2 twice daily 3 times a week. - Recommended: - Children with AIDS and / or CD4 count = or < 500 cells/mm3 should receive primary PCP prophylaxis as described. Concurrent Treatment: Allowed: - Blood transfusion for hemoglobin < 8 g/dl and hematocrit < 24 percent or bone marrow suppression. - Supplemental oxygen with a prestudy PaO2 < 70 mmHg. 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. - Children with lymphoid interstitial proliferation (LIP) are excluded from enrollment unless they have had additional AIDS-defining opportunistic infections, meet ARC criteria, have had two or more serious bacterial infections in the 12 months prior to study entry, have evidence of HIV encephalopathy, or are currently on supplemental oxygen and steroids with a pre-treatment PaO2 < 70 mm Hg. - Children with concurrent LIP and ARC are eligible for inclusion. Thrombocytopenia is an exclusion except if it is HIV-associated. - Children randomized prior to their 13th birthday are eligible. - All lab values must be within 4 weeks of study entry. Prior Medication: Allowed: - Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: - Lymphoid interstitial proliferation (LIP) not requiring steroids and supplemental oxygen or with other lymphoproliferative diseases as their sole clinical evidence of HIV infection. - Known hypersensitivity to immunoglobulin. - Active HIV thrombocytopenia requiring IVIG therapy. Concurrent Medication: Excluded: - Chronic acetaminophen. - Drugs that are metabolized by hepatic glucuronidation should not be used for more than 24 hours without notifying the study physician. - Antibacterial prophylaxis for otitis, sinusitis, or urinary tract infection. - Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP) prior to the first episode of laboratory-documented PCP. - Immunoglobulin (IVIG) therapy required for active HIV thrombocytopenia. Patients with the following will be excluded: - Lymphoid interstitial proliferation (LIP) not requiring steroids and supplemental oxygen or with other lymphoproliferative diseases as their sole clinical evidence of HIV infection. - Known hypersensitivity to immunoglobulin. - Active HIV thrombocytopenia requiring IVIG therapy. - Inability to establish or maintain intravenous access. - Lack of parental or guardian authorization for intravenous access. Prior Medication: Excluded within 4 weeks of study entry: - Any other experimental therapy. - Other antiretroviral agents. - Drugs which cause prolonged neutropenia or significant nephrotoxicity. - Immunoglobulins. - Immunomodulating agents. Active alcohol or drug abuse.
Total Enrollment: 250
Location and Contact Information:
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Columbia Univ Babies' Hosp
New York City, New York, 10032
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Children's Hosp of Seattle
Seattle, Washington, 98105
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Univ of Illinois College of Medicine
Chicago, Illinois, 60612
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Stanford Univ School of Medicine
Menlo Park, California, 94025
United States
Kaiser Permanente / UCLA Med Ctr
Downey, California, 902422814
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Lincoln Hosp Ctr / Pediatrics
Bronx, New York, 10451
United States
Univ of Connecticut Health Ctr / Pediatrics
Farmington, Connecticut, 06032
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00619
Puerto Rico
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, 11203
United States
Northern California Pediatric AIDS Treatment Ctr / UCSF
San Francisco, California, 94143
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Westchester Hosp / New York Med College / Pediatrics
Valhalla, New York, 10595
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Schneider Children's Hosp / Long Island Jewish Med Ctr
New Hyde Park, New York, 11042
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
UPR Children's Hosp / San Juan City Hosp
San Juan, , 00936
Puerto Rico
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Martin Luther King Jr Gen Hosp / UCLA Med Ctr
Los Angeles, California, 900593019
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: ACTG 051;
Study Start Date:
Record last reviewed: May 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000720
Other Hiv Infections Studies:
1. Acupressure to Treat Nausea and Vomiting in HIV/AIDS Patients
2. Phase I Safety Study of anti-HIV Immune Serum Globulin (Human)
3. A Study of Viracept in AIDS Patients with Cytomegalovirus Retinitis
4. KSHV Infection in Blood Donors from Texas
5. A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
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