NCT00002149

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsSinusitis

Keywords

AIDS-Related Opportunistic InfectionsDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexSinusitisEphedrineAcupuncture TherapyDrugs, Chinese HerbalMedicine, Chinese TraditionalDrug CombinationsAntibiotics, CombinedAmoxicillin-Potassium Clavulanate Combination

Interventions

Clavulanate potassiumDRUG
Pseudoephedrine hydrochlorideDRUG
Amoxicillin trihydrateDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Antiviral medication.
  • Patients must have:
  • HIV infection.
  • CD4 count \>= 50 cells/mm3.
  • Recurrent sinusitis.
  • No active opportunistic infection.
  • No disease progression.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immune Enhancement Project

San Francisco, California, 94114, United States

Location

MeSH Terms

Conditions

HIV InfectionsSinusitisAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Clavulanic AcidPseudoephedrineAmoxicillin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRespiratory Tract InfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesPhenethylaminesEthylaminesAmpicillinPenicillin GPenicillinsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-09

Locations

US(1)