Acupuncture and Herbal Treatment of Chronic HIV Sinusitis - Full Text View

Purpose

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.

Condition	Intervention
HIV Infections Sinusitis	Drug: Clavulanate potassium Drug: Pseudoephedrine hydrochloride Drug: Amoxicillin trihydrate


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture HIV/AIDS Potassium Sinusitis

Drug Information available for: Ephedrine Hydrochloride Pseudoephedrine Ephedrine sulfate Potassium bicarbonate Pseudoephedrine hydrochloride Potassium chloride Potassium cation Amoxicillin Amoxicillin sodium Clavulanate potassium

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:


Estimated Enrollment:	40

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


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002149

Locations


United States, California
Immune Enhancement Project
San Francisco, California, United States, 94114

Sponsors and Collaborators

Immune Enhancement Project

More Information


ClinicalTrials.gov Identifier:	NCT00002149 History of Changes
Other Study ID Numbers:	243A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:


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

Additional relevant MeSH terms:


HIV Infections Sinusitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases	Amoxicillin Clavulanic Acid Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Pseudoephedrine Ephedrine Anti-Bacterial Agents Anti-Infective Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Nasal Decongestants

ClinicalTrials.gov processed this record on September 29, 2016