CClinicalTrials.gg
CompletedNCT00002192Updated Jun 24, 2005

Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.

A Phase 2 interventional study of Rifapentine and Ethambutol hydrochloride in Mycobacterium Avium-Intracellulare Infection and HIV Infections, sponsored by Anderson Clinical Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Anderson Clinical Research · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This open-label, sequential study is conducted in two parts: a monotherapy phase and a combination treatment phase.

In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy.

In the combination treatment phase, 12 patients each are randomized to one of three arms:

Arm I: Rifapentine (assigned dose level based on monotherapy phase) plus azithromycin.

Arm II: Rifapentine (assigned dose level) plus clarithromycin. Arm III: Rifapentine (assigned dose level) plus ethambutol.

02

Conditions studied

  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Mycobacterium avium-intracellulare Infection
  • Drug Therapy, Combination
  • Antitubercular Agents
  • Azithromycin
  • Clarithromycin
  • Bacteremia
  • rifapentine
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Anderson Clinical Research is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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).

Exclusion criteria

Exclusion Criteria

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:

Excluded:

  • Prophylactic treatment for MAC with rifabutin or any of the study medications.
  • Azithromycin within the 3 weeks prior to randomization.
  • Any investigational drug during the 4 weeks prior to randomization.
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • DrugRifapentine
  • DrugEthambutol hydrochloride
  • DrugClarithromycin
  • DrugAzithromycin
06

Study locations

1 site
  • Hampton Roads Med Specialists
    Hampton, Virginia 23666, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002192
Lead sponsor
Anderson Clinical Research
Collaborators
Hoechst Marion Roussel
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 1997. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion