Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

NCT ID: NCT00002149

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

HIV Infections; Sinusitis

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

Clavulanate potassium

Intervention Type: DRUG

Pseudoephedrine hydrochloride

Intervention Type: DRUG

Amoxicillin trihydrate

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immune Enhancement Project

OTHER

Sponsor Role: lead

Locations

Immune Enhancement Project

San Francisco, California, United States

Countries

United States

Other Identifiers

243A

Identifier Type: -

Identifier Source: org_study_id