Suspended

Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis

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What is being tested

Pseudoephedrine hydrochloride

+ Guaifenesin

+ Cefuroxime axetil

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNose DiseasesOtorhinolaryngologic DiseasesParanasal Sinus DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexSinusitisHIV Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Univ of California / San Diego Treatment Ctr

San Diego, United StatesOpen Univ of California / San Diego Treatment Ctr in Google Maps

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, United States

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp

The Bronx, United States

Montefiore Family Health Ctr / Bronx Municipal Hosp

The Bronx, United States
Suspended10 Study Centers