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NCT00000811

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

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2001-11-30

Brief Summary

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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

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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. \[AS PER AMENDMENT 05/28/99: This study was closed to infants and children age 19 months and older on 2/15/99; the study is now open to infants age 3 to 18 months (Stage II). Patients who are age 24 months or older at the time of Stage I closure will have end-of-study evaluations and will no longer be followed on protocol. Patients who are less than 24 months of age at the time of Stage I closure will be allowed to continue in the current version of the protocol. Enrollment for children age 3 to 18 months will continue until 50 subjects have been randomized. Because Stage II is an unblinded study, patients who are less than 24 months of age currently enrolled on Version 4.0 will have their study medication regimen unblinded and their atovaquone dose increased.\]

Conditions

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Bacterial Infections Pneumonia, Pneumocystis Carinii HIV Infections

Keywords

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

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Azithromycin

Intervention Type DRUG

Atovaquone

Intervention Type DRUG

Sulfamethoxazole-Trimethoprim

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wayne M Dankner

Role: STUDY_CHAIR

Ram Yogev

Role: STUDY_CHAIR

Walter T Hughes

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham - Pediatric

Birmingham, Alabama, United States

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Univ of South Alabama

Mobile, Alabama, United States

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UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States

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Long Beach Memorial (Pediatric)

Long Beach, California, United States

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Children's Hosp of Los Angeles/UCLA Med Ctr

Los Angeles, California, United States

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

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Cedars Sinai / UCLA Med Ctr

Los Angeles, California, United States

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UCLA Med Ctr / Pediatric

Los Angeles, California, United States

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Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, United States

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Children's Hosp of Oakland

Oakland, California, United States

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UCSF / Moffitt Hosp - Pediatric

San Francisco, California, United States

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Children's Hosp of Denver

Denver, Colorado, United States

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Connecticut Children's Med Ctr

Farmington, Connecticut, United States

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Univ of Connecticut / Farmington

Farmington, Connecticut, United States

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Yale Univ Med School

New Haven, Connecticut, United States

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Howard Univ Hosp

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

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North Broward Hosp District

Fort Lauderdale, Florida, United States

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Univ of Florida Gainesville

Gainesville, Florida, United States

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Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, United States

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Univ of Miami (Pediatric)

Miami, Florida, United States

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Palm Beach County Health Dept

Riviera Beach, Florida, United States

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Emory Univ Hosp / Pediatrics

Atlanta, Georgia, United States

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Med College of Georgia

Augusta, Georgia, United States

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Cook County Hosp

Chicago, Illinois, United States

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Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, United States

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Chicago Children's Memorial Hosp

Chicago, Illinois, United States

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Univ of Chicago Children's Hosp

Chicago, Illinois, United States

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Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, United States

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Earl K Long Early Intervention Clinic

New Orleans, Louisiana, United States

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Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, United States

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Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, United States

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Children's Hosp of Boston

Boston, Massachusetts, United States

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Boston City Hosp / Pediatrics

Boston, Massachusetts, United States

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Baystate Med Ctr of Springfield

Springfield, Massachusetts, United States

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Univ of Massachusetts Med School

Worcester, Massachusetts, United States

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Children's Hosp of Michigan

Detroit, Michigan, United States

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Univ of Mississippi Med Ctr

Jackson, Mississippi, United States

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

Camden, New Jersey, United States

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UMDNJ - Robert Wood Johnson Med School / Pediatrics

New Brunswick, New Jersey, United States

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Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, United States

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

Newark, New Jersey, United States

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Children's Hosp at Albany Med Ctr

Albany, New York, United States

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SUNY - Brooklyn

Brooklyn, New York, United States

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

Buffalo, New York, United States

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North Shore Univ Hosp

Great Neck, New York, United States

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