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

Sponsor:	Immune Enhancement Project
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002149

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Acupuncture Acute Bronchitis Antibiotics HIV/AIDS Potassium Sinusitis

Drug Information available for: Ephedrine Hydrochloride Amoxicillin Amoxicillin sodium Clavulanic acid Clavulanate potassium Amoxicillin trihydrate Amoxicillin-potassium clavulanate combination Ephedrine Pseudoephedrine hydrochloride Potassium chloride Pseudoephedrine Sulfate

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
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

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

No publications provided

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
Acquired Immunodeficiency Syndrome
Sinusitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Pseudoephedrine
Ephedrine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012