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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Azithromycin (Drug); Atovaquone (Drug); Sulfamethoxazole-Trimethoprim (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Wayne M Dankner, Study Chair
Ram Yogev, Study Chair
Walter T Hughes, Study Chair


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.

Clinical Details

Official title: A Randomized, Phase II/III, Double-Blind, Two-Armed Study of Micronized Atovaquone and Azithromycin (AT/AZ) as Compared to Trimethoprim-Sulfamethoxazole (TMP/SMX) in the Prevention of Serious Bacterial Infections When Used in Children Aged 3 Months to 19 Years With HIV Infection

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

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.]


Minimum age: 3 Months. Maximum age: 18 Months. Gender(s): Both.


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.

Locations and Contacts

Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon 00956, Puerto Rico

San Juan City Hosp, San Juan 009367344, Puerto Rico

Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan 009365067, Puerto Rico

Univ of Alabama at Birmingham - Pediatric, Birmingham, Alabama 35233, United States

Univ of South Alabama, Mobile, Alabama 36604, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States

Long Beach Memorial (Pediatric), Long Beach, California 90801, United States

Cedars Sinai / UCLA Med Ctr, Los Angeles, California 900481804, United States

Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles, California 900276016, United States

Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California 905022004, United States

Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States

UCLA Med Ctr / Pediatric, Los Angeles, California 900951752, United States

Children's Hosp of Oakland, Oakland, California 946091809, United States

UCSF / Moffitt Hosp - Pediatric, San Francisco, California 941430105, United States

Children's Hosp of Denver, Denver, Colorado 802181088, United States

Connecticut Children's Med Ctr, Farmington, Connecticut 060303805, United States

Univ of Connecticut / Farmington, Farmington, Connecticut 06032, United States

Yale Univ Med School, New Haven, Connecticut 06504, United States

Howard Univ Hosp, Washington, District of Columbia 20060, United States

North Broward Hosp District, Fort Lauderdale, Florida 33311, United States

Univ of Florida Gainesville, Gainesville, Florida 32610, United States

Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida 32209, United States

Univ of Miami (Pediatric), Miami, Florida 33161, United States

Palm Beach County Health Dept, Riviera Beach, Florida 33404, United States

Emory Univ Hosp / Pediatrics, Atlanta, Georgia 30306, United States

Med College of Georgia, Augusta, Georgia 30912, United States

Chicago Children's Memorial Hosp, Chicago, Illinois 606143394, United States

Cook County Hosp, Chicago, Illinois 60612, United States

Univ of Chicago Children's Hosp, Chicago, Illinois 606371470, United States

Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois 60612, United States

Earl K Long Early Intervention Clinic, New Orleans, Louisiana 70112, United States

Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States

Johns Hopkins Hosp - Pediatric, Baltimore, Maryland 212874933, United States

Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland 21201, United States

Boston City Hosp / Pediatrics, Boston, Massachusetts 02118, United States

Children's Hosp of Boston, Boston, Massachusetts 021155724, United States

Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States

Univ of Massachusetts Med School, Worcester, Massachusetts 016550001, United States

Children's Hosp of Michigan, Detroit, Michigan 48201, United States

Univ of Mississippi Med Ctr, Jackson, Mississippi 39213, United States

Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl, Camden, New Jersey 08103, United States

UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick, New Jersey 089030019, United States

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark, New Jersey 07103, United States

Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey 071032714, United States

Children's Hosp at Albany Med Ctr, Albany, New York 12208, United States

Bronx Lebanon Hosp Ctr, Bronx, New York 10457, United States

Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York 10467, United States

SUNY - Brooklyn, Brooklyn, New York 11203, United States

Children's Hosp Pact Prog / Children's Hosp of Buffalo, Buffalo, New York 14222, United States

North Shore Univ Hosp, Great Neck, New York 11021, United States

Schneider Children's Hosp, New Hyde Park, New York 11040, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Beth Israel Med Ctr / Pediatrics, New York, New York 10003, United States

Columbia Presbyterian Med Ctr, New York, New York 10032, United States

Cornell Univ Med College, New York, New York 10021, United States

Harlem Hosp Ctr, New York, New York 10037, United States

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York 10032, United States

Metropolitan Hosp Ctr, New York, New York 10029, United States

Mount Sinai Med Ctr / Pediatrics, New York, New York 10029, United States

Univ of Rochester Med Ctr, Rochester, New York 146420001, United States

Univ of Rochester Medical Center, Rochester, New York 14642, United States

State Univ of New York at Stony Brook, Stony Brook, New York 117948111, United States

SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York 13210, United States

Duke Univ Med Ctr, Durham, North Carolina 277103499, United States

Columbus Children's Hosp, Columbus, Ohio 432052696, United States

Children's Hosp of Philadelphia, Philadelphia, Pennsylvania 191044318, United States

Saint Christopher's Hosp for Children, Philadelphia, Pennsylvania 191341095, United States

Med Univ of South Carolina, Charleston, South Carolina 294253312, United States

Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee 381052794, United States

Vanderbilt Univ Med Ctr, Nashville, Tennessee 372322581, United States

Hermann Hosp / Univ Texas Health Science Ctr, Houston, Texas 77030, United States

Texas Children's Hosp / Baylor Univ, Houston, Texas 77030, United States

Children's Hosp of the King's Daughters, Norfolk, Virginia 23507, United States

Med College of Virginia, Richmond, Virginia 23219, United States

Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington 981050371, United States

Additional Information

Click here for more information about sulfamethoxazole-trimethoprim

Click here for more information about azithromycin

Haga clic aquí para ver información sobre este ensayo clínico en español.

Related publications:

Ngo LY, Yogev R, Dankner WM, Hughes WT, Xu J, Unadkat J. Pharmacokinetics of azithromycin (AZ) when administered alone and with atovaquone (AT). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:174 (abstract no 506)

Ngo LY, Yogev R, Dankner WM, Hughes WT, Burchett S, Xu J, Sadler B, Unadkat JD. Pharmacokinetics of azithromycin administered alone and with atovaquone in human immunodeficiency virus-infected children. The ACTG 254 Team. Antimicrob Agents Chemother. 1999 Jun;43(6):1516-9.

Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

Last updated: April 2, 2012

Page last updated: August 23, 2015

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