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.

Condition	Treatment or Intervention	Phase
HIV Infections Sinusitis	Drug: Pseudoephedrine hydrochloride  Drug: Guaifenesin  Drug: Cefuroxime axetil  Drug: Beclomethasone dipropionate	Phase II

Further Study Details: 

Expected Total Enrollment:  132

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.

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

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.

California
      Univ of California / San Diego Treatment Ctr, San Diego,  California,  921036325,  United States
      Stanford at Kaiser / Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
New York
      Montefiore Drug Treatment Ctr / Bronx Municipal Hosp, Bronx,  New York,  10461,  United States
      Montefiore Family Health Ctr / Bronx Municipal Hosp, Bronx,  New York,  10461,  United States
      Samaritan Village Inc / Bronx Municipal Hosp, Bronx,  New York,  10461,  United States
      Jack Weiler Hosp / Bronx Municipal Hosp, Bronx,  New York,  10465,  United States
      Montefiore Med Ctr / Bronx Municipal Hosp, Bronx,  New York,  10467,  United States
      Montefiore Med Ctr Adolescent AIDS Program, Bronx,  New York,  10467,  United States
      North Central Bronx Hosp / Bronx Municipal Hosp, Bronx,  New York,  10467,  United States
Pennsylvania
      Thomas Jefferson Univ Hosp, Philadelphia,  Pennsylvania,  191075098,  United States

Study chairs or principal investigators

J Zurlo,  Study Chair
JA McCutchan,  Study Chair

Study ID Numbers:  ACTG 186
Record last reviewed:  February 1993
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000752
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08