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

NCT00000811 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2021-11-04

No results posted yet for this study

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

Interventions

DRUG

Azithromycin

DRUG

Atovaquone

DRUG

Sulfamethoxazole-Trimethoprim

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Glaxo Wellcome

    collaborator INDUSTRY

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Wayne M Dankner

  • Ram Yogev

  • Walter T Hughes

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2001-11-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000811 on ClinicalTrials.gov