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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2011-03-02
200
Participants Needed
50
Research Sites
N/A
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
Trial Site Locations
How is the study designed?
Frequently Asked Questions
Research Publications
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
Who Can Participate
Age: 2Years - 21Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
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).
Exclusion Criteria
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.
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 50 locations
1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Status Unknown
2
Phoenix Childrens Hosp
Phoenix, Arizona, United States, 85006
Status Unknown
3
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Status Unknown
4
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Status Unknown
5
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Status Unknown
6
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
7
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Status Unknown
8
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Status Unknown
9
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Status Unknown
10
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
Status Unknown
11
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Status Unknown
12
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States, 200102916
Status Unknown
13
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
14
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
15
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
16
Palm Beach County Health Dept
Riviera Beach, Florida, United States, 33404
Status Unknown
17
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
Status Unknown
18
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
19
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Status Unknown
20
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
21
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
22
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Status Unknown
23
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
24
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Status Unknown
25
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
26
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
Status Unknown
27
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
Status Unknown
28
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39213
Status Unknown
29
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Status Unknown
30
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
31
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
Status Unknown
32
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
Status Unknown
33
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
34
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Status Unknown
35
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
36
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Status Unknown
37
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
38
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
39
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
Status Unknown
40
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Status Unknown
41
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
42
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Status Unknown
43
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
Status Unknown
44
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
Status Unknown
45
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
46
Med College of Virginia
Richmond, Virginia, United States, 23219
Status Unknown
47
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
48
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, Puerto Rico, 00956
Status Unknown
49
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Status Unknown
50
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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