NCT00002343

Brief Summary

To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

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

June 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Mycobacterium Avium-Intracellulare InfectionHIV Infections

Keywords

RifabutinMycobacterium avium-intracellulare InfectionDrug Therapy, CombinationEthambutolAcquired Immunodeficiency Syndrome

Interventions

Ethambutol hydrochlorideDRUG
RifabutinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Required:
  • AZT, d4T, ddI, or ddC.
  • Antipneumocystis prophylaxis.
  • Allowed:
  • Short course (\< 14 days) of ciprofloxacin for acute infections.
  • Patients must have:
  • AIDS.
  • CD4 count \<= 100 cells/mm3.
  • NO prior or current MAC infection.
  • Prior Medication:
  • Required:
  • Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.
  • Allowed:
  • Prior rifabutin.
  • +2 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Positive tuberculin skin test (PPD \> 5 mm).
  • Active M. tuberculosis.
  • Perceived as unreliable or unavailable for frequent monitoring.
  • Concurrent Medication:
  • Excluded:
  • Other antiretrovirals not specifically allowed.
  • All investigational drugs.
  • Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (\>= 14 days).
  • Patients with the following prior conditions are excluded:
  • Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.
  • Prior Medication:
  • Excluded within 4 weeks prior to study entry:
  • Rifampin.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of California - Davis Med Ctr / CARES

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare InfectionHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

EthambutolRifabutin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-06

Locations

US(1)