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Preventing Frequent Sinus Infections in HIV-Infected Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Adams Laboratories
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000752
First received: November 2, 1999
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
HIV Infections
Sinusitis
Drug: Pseudoephedrine hydrochloride
Drug: Guaifenesin
Drug: Cefuroxime axetil
Drug: Beclomethasone dipropionate
Phase 2

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 0
Study Completion Date: February 1993
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000752

Locations
United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
United States, New York
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10461
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10461
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, United States, 10461
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, United States, 10465
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, United States, 10467
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, United States, 10467
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, United States, 10467
United States, Pennsylvania
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 191075098
Sponsors and Collaborators
Adams Laboratories
Glaxo Wellcome
Investigators
Study Chair: J Zurlo
Study Chair: JA McCutchan
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000752     History of Changes
Other Study ID Numbers: ACTG 186
Study First Received: November 2, 1999
Last Updated: October 24, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
cefuroxime axetil
Beclomethasone
Guaiacol Glyceryl Ether
Sinusitis
Ephedrine

Additional relevant MeSH terms:
Paranasal Sinus Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Sinusitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Beclomethasone
Pseudoephedrine
Guaifenesin
Phenylpropanolamine
Cefuroxime
Cefuroxime axetil
Chlorpheniramine, phenylpropanolamine drug combination
Ephedrine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on April 16, 2014