A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
An Observational Study of the Rate of Opportunistic Infection Events in HIV-Infected Children Who Have Demonstrated Immunologic Reconstitution and Who Have Discontinued OI Prophylaxis
2 other identifiers
interventional
200
2 countries
50
Brief Summary
The purpose of this study is to find out if it is safe for HIV-positive children who are responding well to their anti-HIV treatment to stop taking medications that prevent AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial infections. This is an observational study, meaning children will only be monitored to see if they develop any infections. Children have been receiving medications to prevent complications of HIV infection, such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease, or other bacterial infections. It is common for HIV-positive patients with low CD4 counts to receive these preventive medications. However, these drugs can have serious side effects, they are expensive, and it is possible for bacteria resistant to the drugs to grow. For these reasons, it may be beneficial to the child to stop taking these preventive medications if he/she has been on anti-HIV (antiretroviral) therapy and has improved CD4 counts. This study will look at how many children who stop taking their medications develop opportunistic infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedMarch 2, 2011
July 1, 2005
November 2, 1999
March 1, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Children may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 percent greater than or equal to 25 percent if they are under 6 years of age, or have a CD4 percent greater than or equal to 20 percent on 2 occasions if they are between the ages of 6 and 21.
- Have been receiving preventive treatment for PCP for at least 6 months and have not stopped treatment for more than 3 months before study entry.
- Are willing to stop taking preventive treatment for PCP and MAC.
- Have received the same continuous antiretroviral (anti-HIV) therapy for the 16 weeks before beginning the study. (Continuous therapy means missing no more than a total of 3 weeks during the 16 weeks.)
- Are between the ages of 2 and 21 years (consent of parent or guardian is required if under 18).
You may not qualify if:
- Children will not be eligible for this study if they:
- Have PCP.
- Have any other active infection, such as tuberculosis or toxoplasmosis, or any other significant disease.
- Are receiving chemotherapy for cancer or certain other medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
Phoenix Childrens Hosp
Phoenix, Arizona, 85006, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, 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
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
Children's Hosp of Oakland
Oakland, California, 946091809, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Yale Univ Med School
New Haven, Connecticut, 06504, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103, United States
SUNY - Brooklyn
Brooklyn, New York, 11203, United States
North Shore Univ Hosp
Great Neck, New York, 11021, United States
Schneider Children's Hosp
New Hyde Park, New York, 11040, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Metropolitan Hosp Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Columbus Children's Hosp
Columbus, Ohio, 432052696, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Med College of Virginia
Richmond, Virginia, 23219, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (1)
Weinberg A, Huang S, Fenton T, Patterson-Bartlett J, Gona P, Read JS, Dankner WM, Nachman S; IMPAACT P1008 Team. Virologic and immunologic correlates with the magnitude of antibody responses to the hepatitis A vaccine in HIV-infected children on highly active antiretroviral treatment. J Acquir Immune Defic Syndr. 2009 Sep 1;52(1):17-24. doi: 10.1097/QAI.0b013e3181b011f6.
PMID: 19617848RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wayne Dankner
- STUDY CHAIR
Ram Yogev
- STUDY CHAIR
Walter Hughes