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A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children Clinical research trials and A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children. A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children clinical trial. Participants frequently get the best healthcare available for their A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children  A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , North American Biologicals Inc
Synopsis: To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
Details: Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children. Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 2 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis according to CDC guidelines. Allowed: - Varicella-zoster immunoglobulin. - Hepatitis B immunoglobulin. - Prophylactic therapies not involving immunoglobulin. Patients must have: - HIV infection. - CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years). - Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry. - Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry. - Life expectancy of at least 6 months. Prior Medication: Required: - Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG. - Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia). - Acute illness with temperature >= 100 F and/or with IV antibiotics. - Grade 3 or worse clinical toxicities. - Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min. - Concomitant participation in an experimental antiretroviral or HIV vaccine trial. Concurrent Medication: Excluded: - IVIG. - Chemotherapy for an active malignancy. - MMR or rubella vaccinations. - Intramuscular immunoglobulin. Patients with the following prior condition are excluded: - History of severe reaction to IVIG. Prior Medication: Excluded: - IVIG within the past 60 days. - Chemotherapy for an active malignancy within the past year. - MMR or rubella vaccinations within the past 6 months. - Intramuscular immunoglobulin within the past 60 days. Ongoing drug or alcohol abuse.
Total Enrollment: 45
Location and Contact Information:
Overall Study Official:
StiehmER, Study Chair,
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Vanderbilt School of Medicine
Nashville, Tennessee, 37232
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Additional Information:
Study ID Numbers: ACTG 273;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000827
Other Hiv Infections Studies:
1. Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
2. Withdrawal of Antifungal Treatment for Histoplasmosis in Patients after Improved Immune Response to Anti-HIV Drugs
3. A Prospective Double-Blind Study of Retrovir in Early HIV Infection
4. The Safety and Effectiveness of 524W91
5. The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
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A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
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