NCT00002192

Brief Summary

To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.

Trial Health

80
On Track

Trial Health Score

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

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

August 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Mycobacterium Avium-Intracellulare InfectionHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsMycobacterium avium-intracellulare InfectionDrug Therapy, CombinationAntitubercular AgentsAzithromycinClarithromycinBacteremiarifapentine

Interventions

RifapentineDRUG
Ethambutol hydrochlorideDRUG
ClarithromycinDRUG
AzithromycinDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • Documented positive HIV serology status.
  • Documented AIDS.
  • Positive blood culture for MAC from the study-designated microbiology laboratory. NOTE:
  • Patients with presumed MAC bacteremia, as evidenced by positive blood, bone marrow, or liver biopsy culture analyzed locally, may be enrolled pending confirmation.
  • Minimum of two MAC-associated symptoms, defined as \>= grade 1 fever; \> grade 1 night sweats, fatigue, diarrhea, abdominal pain, or anorexia; or weight loss \> 5% reported within 4 weeks prior to study entry.
  • Life expectancy of at least 3 months.
  • Prior Medication:
  • Allowed:
  • MAC prophylaxis with medications other than study drugs (5-day washout period required).

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Pulmonary tuberculosis.
  • Infections requiring the use of disallowed medications.
  • Serious diseases that introduce undue risks for adverse reactions to study medication.
  • Concurrent Medication:
  • Excluded:
  • Terfenadine.
  • Treatment for pulmonary TB.
  • Study drugs from an outside source.
  • Medications with anti-MAC activity (i.e., amikacin, ciprofloxacin, clofazimine, rifampin, and rifabutin).
  • Patients with the following prior conditions are excluded:
  • History of hypersensitivity to rifabutin, rifampin, clarithromycin, erythromycin, azithromycin, or ethambutol.
  • Previous episode of uveitis.
  • Prior Medication:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hampton Roads Med Specialists

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare InfectionHIV InfectionsAIDS-Related Opportunistic InfectionsBacteremia

Interventions

rifapentineEthambutolClarithromycinAzithromycin

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 DiseasesOpportunistic InfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsErythromycinMacrolidesPolyketidesLactones

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-08

Locations

US(1)