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

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NCT00000811

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Study Location
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections, Pneumocystis Carinii Pneumonia, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-18 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Bacterial Infections, Pneumocystis Carinii Pneumonia, HIV InfectionsA Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
NCT00000811
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. La Jolla, California
  4. Long Beach, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Oakland, California
  11. San Francisco, California
  12. Denver, Colorado
  13. Farmington, Connecticut
  14. Farmington, Connecticut
  15. New Haven, Connecticut
  16. Washington, District of Columbia
  17. Fort Lauderdale, Florida
  18. Gainesville, Florida
  19. Jacksonville, Florida
  20. Miami, Florida
  21. Riviera Beach, Florida
  22. Atlanta, Georgia
  23. Augusta, Georgia
  24. Chicago, Illinois
  25. Chicago, Illinois
  26. Chicago, Illinois
  27. Chicago, Illinois
  28. New Orleans, Louisiana
  29. New Orleans, Louisiana
  30. Baltimore, Maryland
  31. Baltimore, Maryland
  32. Boston, Massachusetts
  33. Boston, Massachusetts
  34. Springfield, Massachusetts
  35. Worcester, Massachusetts
  36. Detroit, Michigan
  37. Jackson, Mississippi
  38. Camden, New Jersey
  39. New Brunswick, New Jersey
  40. Newark, New Jersey
  41. Newark, New Jersey
  42. Albany, New York
  43. Bronx, New York
  44. Bronx, New York
  45. Brooklyn, New York
  46. Buffalo, New York
  47. Great Neck, New York
  48. New Hyde Park, New York
  49. New York, New York
  50. New York, New York
  51. New York, New York
  52. New York, New York
  53. New York, New York
  54. New York, New York
  55. New York, New York
  56. New York, New York
  57. Rochester, New York
  58. Rochester, New York
  59. Stony Brook, New York
  60. Syracuse, New York
  61. Durham, North Carolina
  62. Columbus, Ohio
  63. Philadelphia, Pennsylvania
  64. Philadelphia, Pennsylvania
  65. Charleston, South Carolina
  66. Memphis, Tennessee
  67. Nashville, Tennessee
  68. Houston, Texas
  69. Houston, Texas
  70. Norfolk, Virginia
  71. Richmond, Virginia
  72. Seattle, Washington
  73. Bayamon,
  74. San Juan,
  75. San Juan,
ALL GENDERS
3 Months+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
Official Title  ICMJE 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
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.]

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Infections
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
Intervention  ICMJE
  • Drug: Azithromycin
  • Drug: Atovaquone
  • Drug: Sulfamethoxazole-Trimethoprim
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)		690
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Months to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000811
Other Study ID Numbers  ICMJE ACTG 254
PACTG 254
11231 ( Registry Identifier: DAIDS-ES )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE
  • Pfizer
  • Glaxo Wellcome
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Study Chair:Wayne M Dankner
Study Chair:Ram Yogev
Study Chair:Walter T Hughes
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP