A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
- Conditions
- Bacterial InfectionsPneumonia, Pneumocystis CariniiHIV Infections
- Registration Number
- NCT00000811
- Brief 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.
- Detailed Description
Although SMX/TMP remains the drug of choice for PCP prophylaxis, drug sensitivity may limit its use. Atovaquone has demonstrated greater safety than SMX/TMP and thus is suitable as a candidate drug for treatment and prophylaxis of PCP. Azithromycin, with a broad anti-microbial spectrum (including mycoplasma and atypical mycoplasma), is an attractive prophylactic agent for use in children with HIV infection, due to its relative safety and once-daily dosing regimen. Therefore, the combination of atovaquone and azithromycin may offer broader antimicrobial coverage and greater safety than SMX/TMP.
Patients are randomized to receive either SMX/TMP or combination micronized atovaquone/azithromycin. Crossover to the alternative regimen may occur if serious toxicity is observed. Patients are monitored for occurrence of serious bacterial infections or PCP breakthrough, and when a serious bacterial infection occurs, patients are crossed over to the alternative regimen. Treatment continues until 2 years after the last patient is enrolled. The first 30 patients will undergo a pharmacokinetic profile. Patients are followed every 4 weeks for the first 4 months, then every 8 weeks thereafter. \[AS PER AMENDMENT 05/28/99: This study was closed to infants and children age 19 months and older on 2/15/99; the study is now open to infants age 3 to 18 months (Stage II). Patients who are age 24 months or older at the time of Stage I closure will have end-of-study evaluations and will no longer be followed on protocol. Patients who are less than 24 months of age at the time of Stage I closure will be allowed to continue in the current version of the protocol. Enrollment for children age 3 to 18 months will continue until 50 subjects have been randomized. Because Stage II is an unblinded study, patients who are less than 24 months of age currently enrolled on Version 4.0 will have their study medication regimen unblinded and their atovaquone dose increased.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 690
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
Saint Christopher's Hosp for Children
🇺🇸Philadelphia, Pennsylvania, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
🇺🇸Camden, New Jersey, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
🇺🇸New Brunswick, New Jersey, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
🇺🇸Buffalo, New York, United States
Beth Israel Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Hermann Hosp / Univ Texas Health Science Ctr
🇺🇸Houston, Texas, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Med College of Virginia
🇺🇸Richmond, Virginia, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Tulane Univ / Charity Hosp of New Orleans
🇺🇸New Orleans, Louisiana, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Univ of South Alabama
🇺🇸Mobile, Alabama, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Earl K Long Early Intervention Clinic
🇺🇸New Orleans, Louisiana, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Univ of Florida Gainesville
🇺🇸Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Palm Beach County Health Dept
🇺🇸Riviera Beach, Florida, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
Connecticut Children's Med Ctr
🇺🇸Farmington, Connecticut, United States
Univ of Connecticut / Farmington
🇺🇸Farmington, Connecticut, United States
Univ of Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States