Status:
COMPLETED
A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
2-21 years
Phase:
NA
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 (op...
Detailed 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 se...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00001078
Last Update
March 2 2011
Active Locations (50)
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1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
2
Phoenix Childrens Hosp
Phoenix, Arizona, United States, 85006
3
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
4
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801