Preventing Frequent Sinus Infections in HIV-Infected Patients

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

Keywords

ClinConnect Summary

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.