Expired Study
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Hampton, Virginia 23666


Purpose:

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.


Study summary:

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.


Criteria:

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 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.


Study is Available At:


Original ID:

275A


NCT ID:

NCT00002192


Secondary ID:

000473PR0018


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:August 1997
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Rifapentine
Intervention Type:Drug
Name:Ethambutol hydrochloride
Intervention Type:Drug
Name:Clarithromycin
Intervention Type:Drug
Name:Azithromycin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Anderson Clinical Research
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Hoechst Marion Roussel

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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