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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001078

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

200

Last updated by the study team

2011-03-02

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States
• Phoenix Childrens Hosp — Phoenix, Arizona, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Children's Hosp of Los Angeles/UCLA Med Ctr — Los Angeles, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Children's Hosp of Oakland — Oakland, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Palm Beach County Health Dept — Riviera Beach, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Univ of Maryland at Baltimore / Univ Med Ctr — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Boston City Hosp / Pediatrics — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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