Completed

Phase Not Applicable
Age: 2Years - 21Years
All Genders
ID00001078

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

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

Eligible

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.
Not Eligible

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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Published Research Related To This Trial

Virologic and immunologic correlates with the magnitude of antibody responses to the hepatitis A vaccine in HIV-infected children on highly active antiretroviral treatment.

Adriana Weinberg, Sharon Huang, Terence Fenton...

https://pubmed.ncbi.nlm.nih.gov/19617848