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

Keywords

ClinConnect Summary

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.