Clinical trial NCT00002149: Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Official title: Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sinusitis
Keywords: AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Sinusitis
Ephedrine
Acupuncture Therapy
Drugs, Chinese Herbal
Medicine, Chinese Traditional
Drug Combinations
Antibiotics, Combined
Amoxicillin-Potassium Clavulanate Combination
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Immune Enhancement Project
state: California
Study officials:
References: