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

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.

Study Type: Interventional

Study Design: Treatment, Double-Blind

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.

Intervention(s) in this Clinical Trial

• Drug: Pseudoephedrine hydrochloride
• Drug: Guaifenesin
• Drug: Cefuroxime axetil
• Drug: Beclomethasone dipropionate

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Overall Clinical Trial Officials and Contacts

J Zurlo Study Chair   

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000752

Study ID Number: ACTG 186

ClinicalTrials.gov Identifier: NCT00000752

Health Authority: United States: Federal Government