HIV InfectionsPhase 2NCT00000752
Preventing Frequent Sinus Infections in HIV-Infected Patients
A Phase 2 study testing Pseudoephedrine hydrochloride, Guaifenesin and Cefuroxime axetil in people with HIV Infections and Sinusitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial 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 ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections, Sinusitis
- What is being tested?
- Pseudoephedrine hydrochloride, Guaifenesin and Cefuroxime axetil
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento Feb 1993
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiretroviral agents (both approved and investigational).
- Biologic response modifiers.
- Systemic chemotherapy.
- Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP), candidiasis, and herpes.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, 10461
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, 10461
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, 10467
About this study
Official title: Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis
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.
Read the 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 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.
- Conditions
- HIV Infections, Sinusitis
- Being tested
- Pseudoephedrine hydrochloride, Guaifenesin, Cefuroxime axetil, Beclomethasone dipropionate
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, cefuroxime axetil, Beclomethasone, Guaiacol Glyceryl Ether, Sinusitis, Ephedrine
- Medical subject headings
- HIV Infections, Sinusitis, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudoephedrine hydrochlorideDrug
GuaifenesinDrug
Cefuroxime axetilDrug
Beclomethasone dipropionateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionFeb 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Adams Laboratories, Glaxo Wellcome
- Investigators
- J Zurlo, Study chairJA McCutchan, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000752
- Sponsor's protocol ID
- ACTG 186
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Publications
Zurlo JJ, Feuerstein IM, Lebovics R, Lane HC. Sinusitis in HIV-1 infection. Am J Med. 1992 Aug;93(2):157-62. doi: 10.1016/0002-9343(92)90045-d.
PubMed 1353944
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis
- ClinicalTrials.gov ID
- NCT00000752
- Acronym / sponsor ID
- ACTG 186
- Conditions
- HIV Infections, Sinusitis
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, cefuroxime axetil, Beclomethasone, Guaiacol Glyceryl Ether, Sinusitis, Ephedrine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Adams Laboratories, Glaxo Wellcome
- Study completion
- Feb 1993 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pseudoephedrine hydrochloride | Drug | – |
| Guaifenesin | Drug | – |
| Cefuroxime axetil | Drug | – |
| Beclomethasone dipropionate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 1353944Zurlo JJ, Feuerstein IM, Lebovics R, Lane HC. Sinusitis in HIV-1 infection. Am J Med. 1992 Aug;93(2):157-62. doi: 10.1016/0002-9343(92)90045-d.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Zurlo study chair
JA McCutchan study chair
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pseudoephedrine hydrochloride, Guaifenesin and Cefuroxime axetil in people with HIV Infections and Sinusitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.