Preventing Frequent Sinus Infections in HIV-Infected Patients

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.