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Home > "P" Clinical Trials Conditions > Preventing Frequent Sinus Infections in HIV-Infected Patients  Preventing Frequent Sinus Infections in HIV-Infected Patients
Preventing Frequent Sinus Infections in HIV-Infected Patients
For Condition: HIV Infections,Sinusitis
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Adams Laboratories,Glaxo Wellcome
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 132
Location and Contact Information:
Overall Study Official:
JZurlo, Study Chair,
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Additional Information:
Study ID Numbers: ACTG 186;
Study Start Date:
Record last reviewed: February 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000752
Other Hiv Infections Studies:
1. Evaluation of the Interaction Between Acetaminophen and Zidovudine
2. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
3. The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Who Have Had PCP Before
4. A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children with Immunodeficiency Syndromes
5. A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
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Preventing Frequent Sinus Infections in HIV-Infected Patients
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