Search / Trial NCT00000752

Preventing Frequent Sinus Infections in HIV-Infected Patients

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

Apply for Trial

Trial Information

Current as of December 10, 2023

Withdrawn

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Cefuroxime Axetil Beclomethasone Guaiacol Glyceryl Ether Sinusitis Ephedrine

Description

Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted. Patients receive 21-42 days of antibiotic therapy for the defining episode of sinusitis. Following discontinuation of antibiotics, screening evaluations are performed. Within 7 days following completion of antibiotics, patients with clinical resolution begin 14 +/- 3 days of decongestant therapy with oral De...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral agents (both approved and investigational).
  • Biologic response modifiers.
  • Systemic chemotherapy.
  • Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP), candidiasis, and herpes.
  • Adjuvant systemic corticosteroids with appropriate antibiotic therapy for moderate to severe PCP.
  • Maintenance therapy with pyrimethamine, sulfadiazine, amphotericin B, fluconazole, ketoconazole, or acyclovir.
  • Treatment with ganciclovir, foscarnet, or antimycobacterial drugs for CMV disease or mycobacterial infections.
  • Non-beta lactam antibacterial agents for other infections (beta lactam antibacterial agents are allowed if study drugs are temporarily discontinued).
  • Antihistamines and saline nasal sprays.
  • Concurrent Treatment:
  • Allowed:
  • Radiation therapy.
  • Patients must have:
  • HIV infection.
  • At least one episode of symptomatic maxillary sinusitis, with clinical resolution following antibiotic therapy.
  • Life expectancy of at least 12 months.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Concurrent infection caused by cytomegalovirus or Mycobacterium avium Complex.
  • Significant emotional disorder or psychosis.
  • Conditions such as dementia that would substantially impair study compliance.
  • Evidence of significant malabsorption, ileus, or significant emesis that would inhibit drug absorption.
  • Inability to tolerate a minimum administration of one tablet of oral Deconsal II daily.
  • Concurrent Medication:
  • Excluded:
  • Prescription or over-the-counter nasal steroids, decongestants, or topical vasoconstrictors (ephedrine, oxymetazoline).
  • Patients with the following prior condition are excluded:
  • History of an acute hypersensitivity reaction to any penicillin or cephalosporin, characterized by urticaria, hypotension, or laryngeal edema.
  • Active substance abuse that would impair study compliance.

Attachments

readout_NCT00000752_2023-12-10.pdf

4.5 MB

NCT00000752_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

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

San Diego, California, United States

San Francisco, California, United States

Bronx, New York, United States

Bronx, New York, United States

Philadelphia, Pennsylvania, 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

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?

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?

Discussion 0