Preventing Frequent Sinus Infections in HIV-Infected Patients
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Sinusitis
Intervention: Pseudoephedrine hydrochloride (Drug); Guaifenesin (Drug); Cefuroxime axetil (Drug); Beclomethasone dipropionate (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
J Zurlo, Study Chair
JA McCutchan, Study Chair
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.
Clinical Details
Official title: Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis
Study design: Treatment, Double-Blind
Detailed 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 Deconsal II, a drug combining pseudoephedrine, a decongestant,
and guaifenesin, an expectorant. Following decongestant therapy, patients undergo entry
evaluations, including nasal endoscopy and sinus radiograph. Patients with continued clinical
resolution and no purulence on endoscopy are then randomized to receive decongestant alone or
in combination with nasal steroid (beclomethasone dipropionate) or antibiotic (cefuroxime
axetil) or both. Treatment continues for a minimum of 52 weeks and a maximum of 104 weeks.
Patients are followed at weeks 4, 8, and 12 and every 8 weeks thereafter.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
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, Bronx, New York 10461, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx, New York 10461, United States
Samaritan Village Inc / Bronx Municipal Hosp, Bronx, New York 10461, United States
Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States
Montefiore Med Ctr / Bronx Municipal Hosp, Bronx, New York 10467, United States
Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York 10467, United States
North Central Bronx Hosp / Bronx Municipal Hosp, Bronx, New York 10467, United States
Thomas Jefferson Univ Hosp, Philadelphia, Pennsylvania 191075098, United States
Additional Information
Related publications: Zurlo JJ, Feuerstein IM, Lebovics R, Lane HC. Sinusitis in HIV-1 infection. Am J Med. 1992 Aug;93(2):157-62.
Last updated: June 23, 2005
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