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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Adams Laboratories Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000752 |
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 |
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HIV Infections Sinusitis |
Drug: Pseudoephedrine hydrochloride Drug: Guaifenesin Drug: Cefuroxime axetil Drug: Beclomethasone dipropionate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
Official Title: | Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis |
Estimated 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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
Active substance abuse that would impair study compliance.
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 |
Study Chair: | J Zurlo | |
Study Chair: | JA McCutchan |
Study ID Numbers: | ACTG 186 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000752 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex cefuroxime axetil |
Beclomethasone Guaiacol Glyceryl Ether Sinusitis Ephedrine |
Pseudoephedrine Sexually Transmitted Diseases, Viral Otorhinolaryngologic Diseases Acquired Immunodeficiency Syndrome Beclomethasone AIDS-Related Complex Sinusitis Immunologic Deficiency Syndromes Recurrence Naphazoline Virus Diseases Oxymetazoline |
Cefuroxime axetil Cefuroxime Respiratory Tract Diseases Respiratory Tract Infections Guaifenesin Phenylephrine HIV Infections Sexually Transmitted Diseases Ephedrine Phenylpropanolamine Retroviridae Infections |
Anti-Inflammatory Agents Communicable Diseases Respiratory System Agents Anti-Infective Agents Neurotransmitter Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Agents Paranasal Sinus Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Infection Hormones Nasal Decongestants Anti-Bacterial Agents |
Therapeutic Uses Vasoconstrictor Agents RNA Virus Infections Immune System Diseases Sympathomimetics Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents Glucocorticoids Pharmacologic Actions Nose Diseases Autonomic Agents Expectorants Lentivirus Infections Peripheral Nervous System Agents |