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NCT00000811 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000811
Other study ID # ACTG 254
Secondary ID PACTG 25411231
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date November 2001

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 690
Est. completion date November 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Months
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Azithromycin

• Atovaquone

• Sulfamethoxazole-Trimethoprim

Locations
Country Name City State
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Children's Hosp at Albany Med Ctr Albany New York
United States Emory Univ Hosp / Pediatrics Atlanta Georgia
United States Med College of Georgia Augusta Georgia
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Boston City Hosp / Pediatrics Boston Massachusetts
United States Children's Hosp of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Montefiore Med Ctr Adolescent AIDS Program Bronx New York
United States SUNY - Brooklyn Brooklyn New York
United States Children's Hosp Pact Prog / Children's Hosp of Buffalo Buffalo New York
United States Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl Camden New Jersey
United States Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Cook County Hosp Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
United States Univ of Illinois College of Medicine / Pediatrics Chicago Illinois
United States Columbus Children's Hosp Columbus Ohio
United States Children's Hosp of Denver Denver Colorado
United States Children's Hosp of Michigan Detroit Michigan
United States Duke Univ Med Ctr Durham North Carolina
United States Connecticut Children's Med Ctr Farmington Connecticut
United States Univ of Connecticut / Farmington Farmington Connecticut
United States North Broward Hosp District Fort Lauderdale Florida
United States Univ of Florida Gainesville Gainesville Florida
United States North Shore Univ Hosp Great Neck New York
United States Hermann Hosp / Univ Texas Health Science Ctr Houston Texas
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States Univ of Mississippi Med Ctr Jackson Mississippi
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California
United States Long Beach Memorial (Pediatric) Long Beach California
United States Cedars Sinai / UCLA Med Ctr Los Angeles California
United States Children's Hosp of Los Angeles/UCLA Med Ctr Los Angeles California
United States Harbor - UCLA Med Ctr / UCLA School of Medicine Los Angeles California
United States Los Angeles County - USC Med Ctr Los Angeles California
United States UCLA Med Ctr / Pediatric Los Angeles California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Univ of South Alabama Mobile Alabama
United States Vanderbilt Univ Med Ctr Nashville Tennessee
United States UMDNJ - Robert Wood Johnson Med School / Pediatrics New Brunswick New Jersey
United States Yale Univ Med School New Haven Connecticut
United States Schneider Children's Hosp New Hyde Park New York
United States Earl K Long Early Intervention Clinic New Orleans Louisiana
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr / Pediatrics New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Cornell Univ Med College New York New York
United States Harlem Hosp Ctr New York New York
United States Incarnation Children's Ctr / Columbia Presbyterian Med Ctr New York New York
United States Metropolitan Hosp Ctr New York New York
United States Mount Sinai Med Ctr / Pediatrics New York New York
United States Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark New Jersey
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Children's Hosp of the King's Daughters Norfolk Virginia
United States Children's Hosp of Oakland Oakland California
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States Saint Christopher's Hosp for Children Philadelphia Pennsylvania
United States Med College of Virginia Richmond Virginia
United States Palm Beach County Health Dept Riviera Beach Florida
United States Univ of Rochester Med Ctr Rochester New York
United States Univ of Rochester Medical Center Rochester New York
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States State Univ of New York at Stony Brook Stony Brook New York
United States SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York
United States Howard Univ Hosp Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

Sponsors (4)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Glaxo Wellcome, Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

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. — View 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)

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. — View Citation

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