Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Sinusitis
Intervention: Clavulanate potassium (Drug); Pseudoephedrine hydrochloride (Drug); Amoxicillin trihydrate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Immune Enhancement Project
Summary
To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of
pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin
) in reducing symptoms and recurrence of acute HIV-related sinusitis.
Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with
potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of
life-threatening sepsis, and progress to central nervous system involvement. Symptoms of
sinusitis in HIV patients are often refractory to aggressive Western medical management, and
antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and
herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic
therapy.
Clinical Details
Official title: Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Detailed description:
Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with
potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of
life-threatening sepsis, and progress to central nervous system involvement. Symptoms of
sinusitis in HIV patients are often refractory to aggressive Western medical management, and
antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and
herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic
therapy.
Patients are randomized to receive either Traditional Chinese Medicine (acupuncture and
herbal treatment) or conventional antibiotic therapy (Sudafed and Augmentin). Treatment
continues for 8 weeks, followed by a 4 week washout, with final follow-up at week 12.
Patients must undergo endoscopic nasal exam and CT scan of paranasal sinus prior to study
entry and at week 12.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiviral medication.
Patients must have:
- HIV infection.
- CD4 count >= 50 cells/mm3.
- Recurrent sinusitis.
- No active opportunistic infection.
- No disease progression.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Active infection with fever > 102 F.
- Neurological symptoms such as epidural abscess, subdural hematoma, meningitis, and
dementia.
- Malignant neoplasm of nasal passages.
- Not expected to remain clinically stable for the next 6 months.
- Inability to comply with protocol requirements.
- Malabsorption or inability to take oral medication.
- Concurrent participation on another study where antibiotics will be used.
Concurrent Medication:
Excluded:
- Antibiotics other than Septra.
Concurrent Treatment:
Excluded:
- Chinese herbal medicine or acupuncture unless on that study arm.
- Surgical intervention that has abated symptoms.
Patients with the following prior condition are excluded:
History of allergic reaction to the study antibiotics.
Locations and Contacts
Immune Enhancement Project, San Francisco, California 94114, United States
Additional Information
Last updated: June 23, 2005
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