Preventing Frequent Sinus Infections in HIV-Infected Patients
Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis
1 other identifier
interventional
N/A
1 country
10
Brief Summary
To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. 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.
Trial Health
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10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1993
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- +3 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Adams Laboratoriescollaborator
- Glaxo Wellcomecollaborator
Study Sites (10)
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, 10461, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, United States
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098, United States
Related Publications (1)
Zurlo JJ, Feuerstein IM, Lebovics R, Lane HC. Sinusitis in HIV-1 infection. Am J Med. 1992 Aug;93(2):157-62. doi: 10.1016/0002-9343(92)90045-d.
PMID: 1353944BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
J Zurlo
- STUDY CHAIR
JA McCutchan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1993
Last Updated
October 28, 2021
Record last verified: 2021-10