Preventing Frequent Sinus Infections in HIV-Infected Patients
Withdrawn before enrolling · Phase 2
Conditions studied: HIV Infections, Sinusitis
In brief
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.
Key facts
- Study ID
- NCT00000752
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 0
- Expected to finish
- 1993-02-01
- Last updated by the study team
- 2021-10-28
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Samaritan Village Inc / Bronx Municipal Hosp — The Bronx, New York, United States
- Jack Weiler Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
- Montefiore Med Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
- Montefiore Med Ctr Adolescent AIDS Program — The Bronx, New York, United States
- North Central Bronx Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
- Thomas Jefferson Univ Hosp — Philadelphia, Pennsylvania, United States
- Univ of California / San Diego Treatment Ctr — San Diego, California, United States
- Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
- Montefiore Drug Treatment Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
- Montefiore Family Health Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.