search
Back to results

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

Primary Purpose

Bacterial Infections, Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Azithromycin
Atovaquone
Sulfamethoxazole-Trimethoprim
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiprotozoal Agents, AIDS-Related Complex, Azithromycin, Bacterial Infections, atovaquone

Eligibility Criteria

3 Months - 18 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham - Pediatric
  • Univ of South Alabama
  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • Long Beach Memorial (Pediatric)
  • Children's Hosp of Los Angeles/UCLA Med Ctr
  • Los Angeles County - USC Med Ctr
  • Cedars Sinai / UCLA Med Ctr
  • UCLA Med Ctr / Pediatric
  • Harbor - UCLA Med Ctr / UCLA School of Medicine
  • Children's Hosp of Oakland
  • UCSF / Moffitt Hosp - Pediatric
  • Children's Hosp of Denver
  • Connecticut Children's Med Ctr
  • Univ of Connecticut / Farmington
  • Yale Univ Med School
  • Howard Univ Hosp
  • North Broward Hosp District
  • Univ of Florida Gainesville
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami (Pediatric)
  • Palm Beach County Health Dept
  • Emory Univ Hosp / Pediatrics
  • Med College of Georgia
  • Cook County Hosp
  • Univ of Illinois College of Medicine / Pediatrics
  • Chicago Children's Memorial Hosp
  • Univ of Chicago Children's Hosp
  • Tulane Univ / Charity Hosp of New Orleans
  • Earl K Long Early Intervention Clinic
  • Univ of Maryland at Baltimore / Univ Med Ctr
  • Johns Hopkins Hosp - Pediatric
  • Children's Hosp of Boston
  • Boston City Hosp / Pediatrics
  • Baystate Med Ctr of Springfield
  • Univ of Massachusetts Med School
  • Children's Hosp of Michigan
  • Univ of Mississippi Med Ctr
  • Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
  • UMDNJ - Robert Wood Johnson Med School / Pediatrics
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
  • Children's Hosp at Albany Med Ctr
  • Bronx Lebanon Hosp Ctr
  • Montefiore Med Ctr Adolescent AIDS Program
  • SUNY - Brooklyn
  • Children's Hosp Pact Prog / Children's Hosp of Buffalo
  • North Shore Univ Hosp
  • Schneider Children's Hosp
  • Beth Israel Med Ctr / Pediatrics
  • Bellevue Hosp / New York Univ Med Ctr
  • Cornell Univ Med College
  • Metropolitan Hosp Ctr
  • Mount Sinai Med Ctr / Pediatrics
  • Columbia Presbyterian Med Ctr
  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
  • Harlem Hosp Ctr
  • Univ of Rochester Med Ctr
  • Univ of Rochester Medical Center
  • State Univ of New York at Stony Brook
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • Duke Univ Med Ctr
  • Columbus Children's Hosp
  • Children's Hosp of Philadelphia
  • Saint Christopher's Hosp for Children
  • Med Univ of South Carolina
  • Saint Jude Children's Research Hosp of Memphis
  • Vanderbilt Univ Med Ctr
  • Hermann Hosp / Univ Texas Health Science Ctr
  • Texas Children's Hosp / Baylor Univ
  • Children's Hosp of the King's Daughters
  • Med College of Virginia
  • Children's Hospital & Medical Center / Seattle ACTU
  • Ramon Ruiz Arnau Univ Hosp / Pediatrics
  • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Pfizer, Glaxo Wellcome, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000811
Brief Title
A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
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 Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Pfizer, Glaxo Wellcome, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

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.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
690 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Type
Drug
Intervention Name(s)
Atovaquone
Intervention Type
Drug
Intervention Name(s)
Sulfamethoxazole-Trimethoprim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne M Dankner
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ram Yogev
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walter T Hughes
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham - Pediatric
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Univ of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Long Beach Memorial (Pediatric)
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Children's Hosp of Los Angeles/UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276016
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900481804
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
Children's Hosp of Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
946091809
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Children's Hosp of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
802181088
Country
United States
Facility Name
Connecticut Children's Med Ctr
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
060303805
Country
United States
Facility Name
Univ of Connecticut / Farmington
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale Univ Med School
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Univ of Florida Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Palm Beach County Health Dept
City
Riviera Beach
State/Province
Florida
ZIP/Postal Code
33404
Country
United States
Facility Name
Emory Univ Hosp / Pediatrics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Illinois College of Medicine / Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Earl K Long Early Intervention Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ of Maryland at Baltimore / Univ Med Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Boston City Hosp / Pediatrics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
Children's Hosp of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Univ of Mississippi Med Ctr
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Med School / Pediatrics
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Children's Hosp at Albany Med Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
SUNY - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Children's Hosp Pact Prog / Children's Hosp of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
North Shore Univ Hosp
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell Univ Med College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Metropolitan Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
146420001
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
SUNY Health Sciences Ctr at Syracuse / Pediatrics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Saint Christopher's Hosp for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191341095
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372322581
Country
United States
Facility Name
Hermann Hosp / Univ Texas Health Science Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hosp / Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hosp of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Med College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Children's Hospital & Medical Center / Seattle ACTU
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
Country
United States
Facility Name
Ramon Ruiz Arnau Univ Hosp / Pediatrics
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Univ of Puerto Rico / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
10348786
Citation
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.
Results Reference
background
PubMed Identifier
21037891
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs