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Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults

Primary Purpose

Staphylococcus Aureus, HIV Infections

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

rifabutin plus trimethoprim sulfamethoxazole

placebo plus trimethoprim-sulfamethoxazole

About this trial

This is an interventional treatment trial for Staphylococcus Aureus focused on measuring Staphylococcus aureus, colonization, eradication, HIV, rifabutin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years
HIV infection as reported by the subject's physician
Physician-reported SSSI within the prior 6 months.
S. aureus colonization at ≥ 1 body site as defined as a positive culture for S. aureus at minimum one of five cultures taken at pre-enrollment screening.
Subjects (or their legally acceptable representatives) must have signed an informed consent documentation indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study

Exclusion Criteria:

Female subjects who are pregnant or lactating.
Known or suspected hypersensitivity to rifabutin, a rifamycin class antimicrobial, TMP-SMX or another sulfa based medication.
Known or suspected condition or concurrent treatment that would be contraindicated by the prescribing of rifabutin or TMP-SMX.
Receipt of an anti-staphylococcal antimicrobial within 14 days prior to administration of study drug (TMP-SMX, clindamycin, any macrolide, any tetracycline, any rifamycin, any fluoroquinolone, vancomycin, linezolid, daptomycin, any penicillin, any carbapenem, or any cephalosporin).
Diagnosis of an active SSSI or other signs and symptoms of S. aureus infection at the time of study enrollment
Physician-reported diagnosis of active or untreated latent mycobacterial infection
CrCl < 30 ml/min as determined by the Cockcroft-Gault Method using a serum creatinine from a value obtained within the last 6 months.
No serum creatinine value available for the subject in the SFGH clinical laboratory system (LCR) within 6 months prior to enrollment.
Physician-reported diagnosis of end-stage liver disease
Physician-reported diagnosis of uveitis in the past or at time of enrollment
Concomitant use of medications with unknown pharmacokinetic interactions with rifabutin or contraindicated with rifabutin (unboosted indinavir, unboosted saquinavir, delavirdine, atovaquone, azithromycin, Bacillus of Calmette and Guerin [only if recent administration for bladder cancer treatment], dapsone, dasatinib, erlotininb, ethinyl estradiol, fluconazole, imatinab, itinotecan, itraconazole, ixabepilone, lapatinib, levonorgestrel, mestranol, nilotininb, norelgestromin, norethindrone, posaconazole, ranolazine, sirolimus, sunitinib, tacrolimus, temsirolimus, trimetrexate, voriconazole, warfarin)
Colonizing S. aureus isolate resistant to TMP-SMX
Colonizing S. aureus isolate resistant to rifampin (rifampin resistance will serve as a surrogate for rifabutin resistance at initial screening)
Subjects who are unlikely to be able to comply with the mandated study visits

Sites / Locations

San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rifabutin

Placebo

Arm Description

Subjects will be assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole

Subjects will be assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole

Outcomes

Primary Outcome Measures

Eradication of S. Aureus Colonization

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin

Secondary Outcome Measures

Eradication of S. Aureus Colonization

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin

Eradication of S. Aureus Colonization

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin

Recurrent Skin and Skin Structure Infections (SSTI)

recurrent SSTI was by self-report and exam, followed until positive colonization

Full Information

NCT ID

NCT00869518

First Posted

March 24, 2009

Last Updated

April 23, 2014

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00869518

Brief Title

Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults

Official Title

Randomized, Double-Blinded Evaluation of Rifabutin Based Therapy for Eradication of Staphylococcus Aureus Carriage in HIV Infected Individuals With Prior Skin and Skin Structure Infections

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Poor enrollment

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

DESIGN: This single center, double-blinded, randomized phase II study is being conducted to assess the efficacy of a rifabutin based regimen to eliminate S. aureus colonization in HIV infected individuals. Individuals must have HIV infection and a skin and skin structure infection (SSSI) in the prior 6 months to be eligible for screening. Prior to enrollment, subjects will be cultured for evidence of S. aureus colonization. Individuals who are culture positive at ≥ one body site will be eligible for enrollment. Subjects who meet inclusion and exclusion criteria and consent to participate in the study will be randomized to seven days of rifabutin plus trimethoprim-sulfamethoxazole (TMP-SMX) or TMP-SMX alone. Following completion of treatment subjects will be screened seven days, 30 days, and 60 days post-treatment for colonization at multiple body-sites. Subjects will also be actively followed for evidence of SSSI. SUBJECT PARTICIPATION DURATION: 12 weeks SAMPLE SIZE: 88 total subjects POPULATION: 200 HIV infected individuals who receive care at San Francisco General Hospital HIV clinic (Ward 86) with a history of SSSI in the prior 6 months will be screened for S. aureus colonization. DESCRIPTION OF AGENT OR INTERVENTION: This is a double-blind trial comparing rifabutin plus TMP-SMX versus placebo plus TMP-SMX. Placebo will be administered at a dose of 300 mg p.o. daily or an equivalent dose depending on co-administration of other drugs that may adjust the serum level of rifabutin. TMP-SMX will be administered at a dose of trimethoprim 160 mg and sulfamethoxazole 800 mg p.o. twice daily or adjusted per CrCl. Study drug will be provided by the study and administered for 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcus Aureus, HIV Infections

Keywords

Staphylococcus aureus, colonization, eradication, HIV, rifabutin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rifabutin

Arm Type

Active Comparator

Arm Description

Subjects will be assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will be assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole

Intervention Type

Drug

Intervention Name(s)

rifabutin plus trimethoprim sulfamethoxazole

Intervention Description

rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days

Intervention Type

Drug

Intervention Name(s)

placebo plus trimethoprim-sulfamethoxazole

Intervention Description

placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days

Primary Outcome Measure Information:

Title

Eradication of S. Aureus Colonization

Description

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin

Time Frame

30 days following completion of treatment

Secondary Outcome Measure Information:

Title

Eradication of S. Aureus Colonization

Description

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin

Time Frame

7 days following completion of treatment

Title

Eradication of S. Aureus Colonization

Description

Eradication was measured by performing cultures for S aureus at the nose, throat, and groin

Time Frame

60 days following completion of treatment

Title

Recurrent Skin and Skin Structure Infections (SSTI)

Description

recurrent SSTI was by self-report and exam, followed until positive colonization

Time Frame

up to 30 days following completion of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years HIV infection as reported by the subject's physician Physician-reported SSSI within the prior 6 months. S. aureus colonization at ≥ 1 body site as defined as a positive culture for S. aureus at minimum one of five cultures taken at pre-enrollment screening. Subjects (or their legally acceptable representatives) must have signed an informed consent documentation indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study Exclusion Criteria: Female subjects who are pregnant or lactating. Known or suspected hypersensitivity to rifabutin, a rifamycin class antimicrobial, TMP-SMX or another sulfa based medication. Known or suspected condition or concurrent treatment that would be contraindicated by the prescribing of rifabutin or TMP-SMX. Receipt of an anti-staphylococcal antimicrobial within 14 days prior to administration of study drug (TMP-SMX, clindamycin, any macrolide, any tetracycline, any rifamycin, any fluoroquinolone, vancomycin, linezolid, daptomycin, any penicillin, any carbapenem, or any cephalosporin). Diagnosis of an active SSSI or other signs and symptoms of S. aureus infection at the time of study enrollment Physician-reported diagnosis of active or untreated latent mycobacterial infection CrCl < 30 ml/min as determined by the Cockcroft-Gault Method using a serum creatinine from a value obtained within the last 6 months. No serum creatinine value available for the subject in the SFGH clinical laboratory system (LCR) within 6 months prior to enrollment. Physician-reported diagnosis of end-stage liver disease Physician-reported diagnosis of uveitis in the past or at time of enrollment Concomitant use of medications with unknown pharmacokinetic interactions with rifabutin or contraindicated with rifabutin (unboosted indinavir, unboosted saquinavir, delavirdine, atovaquone, azithromycin, Bacillus of Calmette and Guerin [only if recent administration for bladder cancer treatment], dapsone, dasatinib, erlotininb, ethinyl estradiol, fluconazole, imatinab, itinotecan, itraconazole, ixabepilone, lapatinib, levonorgestrel, mestranol, nilotininb, norelgestromin, norethindrone, posaconazole, ranolazine, sirolimus, sunitinib, tacrolimus, temsirolimus, trimetrexate, voriconazole, warfarin) Colonizing S. aureus isolate resistant to TMP-SMX Colonizing S. aureus isolate resistant to rifampin (rifampin resistance will serve as a surrogate for rifabutin resistance at initial screening) Subjects who are unlikely to be able to comply with the mandated study visits

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry F Chambers, MD

Organizational Affiliation

University of Califronia, San Francisco

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Brian S Schwartz, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco General Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults

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