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

• Status: Completed
• Trial end date: 2001-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Glaxo Wellcome; Pfizer
• Treatments: Atovaquone; Azithromycin; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

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.