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

NCT00000811 | Completed Phase 2

• 3 other identifiers: ACTG 254PACTG 25411231
• Study Type: interventional
• Target: 690
• Locations: 2 countries
• Sites: 75

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.

Conditions

Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

Trimethoprim-Sulfamethoxazole Combination; Pneumonia, Pneumocystis carinii; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Antiprotozoal Agents; AIDS-Related Complex; Azithromycin; Bacterial Infections; atovaquone

Interventions

Azithromycin DRUG

Atovaquone DRUG

Sulfamethoxazole-Trimethoprim DRUG

Eligibility Criteria

• Age: 3 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Pfizer: collaborator
• Glaxo Wellcome: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (75)

Univ of Alabama at Birmingham - Pediatric

Birmingham, Alabama, 35233, United States

Location

Univ of South Alabama

Mobile, Alabama, 36604, United States

Location

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, 920930672, United States

Location

Long Beach Memorial (Pediatric)

Long Beach, California, 90801, United States

Location

Children's Hosp of Los Angeles/UCLA Med Ctr

Los Angeles, California, 900276016, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Cedars Sinai / UCLA Med Ctr

Los Angeles, California, 900481804, United States

Location

UCLA Med Ctr / Pediatric

Los Angeles, California, 900951752, United States

Location

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, 905022004, United States

Location

Children's Hosp of Oakland

Oakland, California, 946091809, United States

Location

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, 941430105, United States

Location

Children's Hosp of Denver

Denver, Colorado, 802181088, United States

Location

Connecticut Children's Med Ctr

Farmington, Connecticut, 060303805, United States

Location

Univ of Connecticut / Farmington

Farmington, Connecticut, 06032, United States

Location

Yale Univ Med School

New Haven, Connecticut, 06504, United States

Location

Howard Univ Hosp

Washington D.C., District of Columbia, 20060, United States

Location

North Broward Hosp District

Fort Lauderdale, Florida, 33311, United States

Location

Univ of Florida Gainesville

Gainesville, Florida, 32610, United States

Location

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, 32209, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Palm Beach County Health Dept

Riviera Beach, Florida, 33404, United States

Location

Emory Univ Hosp / Pediatrics

Atlanta, Georgia, 30306, United States

Location

Med College of Georgia

Augusta, Georgia, 30912, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, 60612, United States

Location

Chicago Children's Memorial Hosp

Chicago, Illinois, 606143394, United States

Location

Univ of Chicago Children's Hosp

Chicago, Illinois, 606371470, United States

Location

Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, 701122699, United States

Location

Earl K Long Early Intervention Clinic

New Orleans, Louisiana, 70112, United States

Location

Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, 212874933, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

Boston City Hosp / Pediatrics

Boston, Massachusetts, 02118, United States

Location

Baystate Med Ctr of Springfield

Springfield, Massachusetts, 01199, United States

Location

Univ of Massachusetts Med School

Worcester, Massachusetts, 016550001, United States

Location

Children's Hosp of Michigan

Detroit, Michigan, 48201, United States

Location

Univ of Mississippi Med Ctr

Jackson, Mississippi, 39213, United States

Location

Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl

Camden, New Jersey, 08103, United States

Location

UMDNJ - Robert Wood Johnson Med School / Pediatrics

New Brunswick, New Jersey, 089030019, United States

Location

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, 071032714, United States

Location

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl

Newark, New Jersey, 07103, United States

Location

Children's Hosp at Albany Med Ctr

Albany, New York, 12208, United States

Location

SUNY - Brooklyn

Brooklyn, New York, 11203, United States

Location

Children's Hosp Pact Prog / Children's Hosp of Buffalo

Buffalo, New York, 14222, United States

Location

North Shore Univ Hosp

Great Neck, New York, 11021, United States

Location

Schneider Children's Hosp

New Hyde Park, New York, 11040, United States

Location

Beth Israel Med Ctr / Pediatrics

New York, New York, 10003, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Cornell Univ Med College

New York, New York, 10021, United States

Location

Metropolitan Hosp Ctr

New York, New York, 10029, United States

Location

Mount Sinai Med Ctr / Pediatrics

New York, New York, 10029, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 146420001, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

State Univ of New York at Stony Brook

Stony Brook, New York, 117948111, United States

Location

SUNY Health Sciences Ctr at Syracuse / Pediatrics

Syracuse, New York, 13210, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10457, United States

Location

Montefiore Med Ctr Adolescent AIDS Program

The Bronx, New York, 10467, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Columbus Children's Hosp

Columbus, Ohio, 432052696, United States

Location

Children's Hosp of Philadelphia

Philadelphia, Pennsylvania, 191044318, United States

Location

Saint Christopher's Hosp for Children

Philadelphia, Pennsylvania, 191341095, United States

Location

Med Univ of South Carolina

Charleston, South Carolina, 294253312, United States

Location

Saint Jude Children's Research Hosp of Memphis

Memphis, Tennessee, 381052794, United States

Location

Vanderbilt Univ Med Ctr

Nashville, Tennessee, 372322581, United States

Location

Hermann Hosp / Univ Texas Health Science Ctr

Houston, Texas, 77030, United States

Location

Texas Children's Hosp / Baylor Univ

Houston, Texas, 77030, United States

Location

Children's Hosp of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Med College of Virginia

Richmond, Virginia, 23219, United States

Location

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

Ramon Ruiz Arnau Univ Hosp / Pediatrics

Bayamón, 00956, Puerto Rico

Location

Univ of Puerto Rico / Univ Children's Hosp AIDS

San Juan, 009365067, Puerto Rico

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

Related Publications (3)

• 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)

  BACKGROUND

• 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. doi: 10.1128/AAC.43.6.1516.

  PMID: 10348786 BACKGROUND

• 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.

  PMID: 21037891 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections; Pneumonia, Pneumocystis; HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Azithromycin; Atovaquone; Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Mycoses; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Naphthoquinones; Quinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Wayne M Dankner

  STUDY CHAIR

• Ram Yogev

  STUDY CHAIR

• Walter T Hughes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: November 1, 2001
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (72); PR (3)