Status:
WITHDRAWN
Preventing Frequent Sinus Infections in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Adams Laboratories
Glaxo Wellcome
Conditions:
HIV Infections
Sinusitis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 ) alo...
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 p...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1993
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000752
End Date
February 1 1993
Last Update
October 28 2021
Active Locations (10)
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1
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
2
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
3
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
4
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461