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Preventing Frequent Sinus Infections in HIV-Infected Patients

Primary Purpose

HIV Infections, Sinusitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pseudoephedrine hydrochloride
Guaifenesin
Cefuroxime axetil
Beclomethasone dipropionate
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, cefuroxime axetil, Beclomethasone, Guaiacol Glyceryl Ether, Sinusitis, Ephedrine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of California / San Diego Treatment Ctr
  • Stanford at Kaiser / Kaiser Permanente Med Ctr
  • Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
  • Montefiore Family Health Ctr / Bronx Municipal Hosp
  • Samaritan Village Inc / Bronx Municipal Hosp
  • Jack Weiler Hosp / Bronx Municipal Hosp
  • Montefiore Med Ctr / Bronx Municipal Hosp
  • Montefiore Med Ctr Adolescent AIDS Program
  • North Central Bronx Hosp / Bronx Municipal Hosp
  • Thomas Jefferson Univ Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Adams Laboratories, Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000752
Brief Title
Preventing Frequent Sinus Infections in HIV-Infected Patients
Official Title
Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1993 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Adams Laboratories, Glaxo Wellcome

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sinusitis
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, cefuroxime axetil, Beclomethasone, Guaiacol Glyceryl Ether, Sinusitis, Ephedrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pseudoephedrine hydrochloride
Intervention Type
Drug
Intervention Name(s)
Guaifenesin
Intervention Type
Drug
Intervention Name(s)
Cefuroxime axetil
Intervention Type
Drug
Intervention Name(s)
Beclomethasone dipropionate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Zurlo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
JA McCutchan
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
921036325
Country
United States
Facility Name
Stanford at Kaiser / Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Family Health Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Samaritan Village Inc / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Jack Weiler Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Montefiore Med Ctr / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Central Bronx Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Thomas Jefferson Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191075098
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1353944
Citation
Zurlo JJ, Feuerstein IM, Lebovics R, Lane HC. Sinusitis in HIV-1 infection. Am J Med. 1992 Aug;93(2):157-62. doi: 10.1016/0002-9343(92)90045-d.
Results Reference
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Preventing Frequent Sinus Infections in HIV-Infected Patients

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