Search / Trial NCT00000816

Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Trimethoprim Sulfamethoxazole Combination Pneumonia, Pneumocystis Carinii Acquired Immunodeficiency Syndrome Aids Related Complex Sulfamethoxazole Trimethoprim

Description

Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred. Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily f...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed if clinically indicated:
  • Recombinant erythropoietin (rEPO) and G-CSF.
  • Allowed for symptomatic treatment of mild study drug toxicity:
  • Antipyretics and analgesics (ibuprofen).
  • Antihistamines (diphenhydramine HCl).
  • Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use).
  • Systemic steroids.
  • Patients must have:
  • HIV infection.
  • CD4 count <= 250 cells/mm3 OR history or presence of thrush.
  • No history of confirmed or probable pneumocystosis.
  • NOTE:
  • Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment.
  • This study is appropriate for prisoner participation.
  • Coenrollment in ongoing ACTG antiretroviral studies is permitted provided no new study drugs are added to the patient's drug regimen for 4 weeks before or after initiation of SMX/TMP.
  • Prior Medication:
  • Allowed:
  • Prior aerosolized pentamidine and dapsone for primary PCP prophylaxis.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Known adverse reactions to sulfa, trimethoprim, or SMX/TMP.
  • Inability to comply with dosing schedule or complete dosing record.
  • Concurrent Medication:
  • Excluded:
  • Procysteine.
  • Glutathione.
  • N-acetylcysteine (NAC).
  • Antihistamines (unless used for symptomatic treatment of study drug toxicity).
  • Systemic corticosteroids (unless used for replacement purposes).
  • Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity).
  • TMP or sulfa drugs outside of the study.
  • Prior Medication:
  • Excluded at any time:
  • Prior SMX/TMP as primary PCP prophylaxis.
  • Excluded within 4 weeks prior to study entry:
  • Initiation of antiretroviral agents.
  • Initiation of anti-infective agents (including SMX/TMP for another indication).
  • Excluded within 2 weeks prior to study entry:
  • Antihistamines.
  • Procysteine.
  • Glutathione.
  • N-acetylcysteine (NAC).
  • Systemic corticosteroids (unless used for replacement purposes).
  • Leucovorin calcium.
  • TMP and sulfa drugs separately.

Attachments

readout_NCT00000816_2024-06-13.pdf

4.5 MB

NCT00000816_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Palo Alto, California, United States

San Francisco, California, United States

San Jose, California, United States

San Mateo, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Omaha, Nebraska, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

Mbeya, , Tanzania

San Juan, , Puerto Rico

Jacksonville, Florida, United States

Honolulu, Hawaii, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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