Preventing Frequent Sinus Infections in HIV-Infected Patients

Phase 2

Withdrawn

• Conditions: HIV Infections; Sinusitis

• Registration Number: NCT00000752
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

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.

Study Timeline

• Study Completion: 1993-02
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Univ of California / San Diego Treatment Ctr; 🇺🇸 San Diego, California, United States

Thomas Jefferson Univ Hosp; 🇺🇸 Philadelphia, Pennsylvania, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp; 🇺🇸 Bronx, New York, United States

Montefiore Family Health Ctr / Bronx Municipal Hosp; 🇺🇸 Bronx, New York, United States

Samaritan Village Inc / Bronx Municipal Hosp; 🇺🇸 Bronx, New York, United States

Jack Weiler Hosp / Bronx Municipal Hosp; 🇺🇸 Bronx, New York, United States

Montefiore Med Ctr Adolescent AIDS Program; 🇺🇸 Bronx, New York, United States

North Central Bronx Hosp / Bronx Municipal Hosp; 🇺🇸 Bronx, New York, United States

Montefiore Med Ctr / Bronx Municipal Hosp; 🇺🇸 Bronx, New York, United States