Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety