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

Completed · Phase 2

Conditions studied: Bacterial Infections, Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000811

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

690

Expected to finish

2001-11-01

Last updated by the study team

2021-11-04

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of South Alabama — Mobile, Alabama, 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
• Cedars Sinai / UCLA Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — 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
• Connecticut Children's Med Ctr — Farmington, Connecticut, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• Univ of Florida Gainesville — Gainesville, Florida, 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
• Med College of Georgia — Augusta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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