Search / Trial NCT00001078

A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of December 10, 2023

Completed

Keywords

Viral Vaccines Aids Related Opportunistic Infections Anti Hiv Agents Hepatitis A Virus, Human

Description

Due to the strong correlation between a significant decrease in CD4 count and the frequency and magnitude of OIs such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC), and severe bacterial infections, CD4 count has become the major criterion for initiating antimicrobial prophylaxis for OIs. However, despite the benefits of these antimicrobial drugs, all are associated with adverse side effects, and patients with reconstituted immune systems following antiretroviral therapy may be receiving prophylaxis unnecessarily. Benefits to stopping prophylaxis include: (1) eli...

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00001078_2023-12-10.pdf

4.5 MB

NCT00001078_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Springfield, Massachusetts, United States

Seattle, Washington, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Oakland, California, United States

San Francisco, California, United States

Denver, Colorado, United States

New Haven, Connecticut, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

New Brunswick, New Jersey, United States

Newark, New Jersey, United States

Brooklyn, New York, United States

Great Neck, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Stony Brook, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Newark, New Jersey, United States

Bronx, New York, United States

Los Angeles, California, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Jacksonville, Florida, United States

Rochester, New York, United States

Birmingham, Alabama, United States

Riviera Beach, Florida, United States

Jackson, Mississippi, United States

Richmond, Virginia, United States

Phoenix, Arizona, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0