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A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children Clinical research trials and A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children. A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children clinical trial. Human subjects frequently get the finest healthcare available for their A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children  A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
For Condition: Bacterial Infections,Pneumonia, Pneumocystis carinii,HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Pfizer,Glaxo Wellcome,National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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.]
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/18 Months
Genders: Both
Protocol Entry 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.
Total Enrollment: 690
Location and Contact Information:
Overall Study Official:
WayneDankner, Study Chair,
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of South Alabama
Mobile, Alabama, 36604
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372322581
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, 08103
United States
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, 70112
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Cornell Univ Med College
New York City, New York, 10021
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Additional Information:
Study ID Numbers: ACTG 254; PACTG 254
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000811
Other Hiv Infections Studies:
1. A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)
2. HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
3. Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
4. Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) Use with Certain Anti-HIV Drugs in HIV-Infected Women
5. Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
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