CompletedPhase 2

A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

United States690 participants

Plain-language summary

This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs. SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.

Who can participate

Age range3 Months – 18 Months

SexALL

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Inclusion Criteria Children may be eligible for this study if they: * Are HIV-positive. * Are between the age of 3 months and 18 months (consent of parent or guardian required). (This study has been changed. In an earlier version, patients up to 19 years old were eligible.) * Are at risk for developing pneumonia and need preventive treatment. * Have a CD4 count of less than 1,500 cells/mm3 if under 1 year of age or a CD4 count of less then 500 cells/mm3 if between 1 and 2 years of age. Exclusion Criteria Children will not be eligible for this study if they: * Have an infection that requires treatment. * Are allergic to atovaquone, azithromycin, or SMX/TMP. * Have serious diarrhea for more than 1 week.

Trial details

NCT IDNCT00000811

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

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