Completed

Traditional Chinese Medicine for Chronic HIV Sinusitis

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What is being tested

Clavulanate potassium

+ Pseudoephedrine hydrochloride

+ Amoxicillin trihydrate

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorImmune Enhancement Project
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorImmune Enhancement Project
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNose DiseasesOpportunistic InfectionsOtorhinolaryngologic DiseasesParanasal Sinus DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexSinusitisHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

6 inclusion criteria required to participate
CD4 count >= 50 cells/mm3.

No disease progression.

No active opportunistic infection.

Recurrent sinusitis.

Show More Criteria

11 exclusion criteria prevent from participating
Surgical intervention that has abated symptoms.

Malignant neoplasm of nasal passages.

Not expected to remain clinically stable for the next 6 months.

Active infection with fever > 102 F.

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Immune Enhancement Project

San Francisco, United StatesOpen Immune Enhancement Project in Google Maps
CompletedOne Study Center