Clinical Trials

MainTitle

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

This study has been terminated
( Poor enrollment )

Sponsor
University of California, San Francisco


Information provided by (Responsible Party)
University of California, San Francisco
ClinicalTrials.gov Identifier
NCT00869518

First received: March 24, 2009
Last updated: April 23, 2014
Last Verified: April 2014
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Staphylococcus Aureus
HIV Infections

Drug : rifabutin plus trimethoprim sulfamethoxazole
Drug : placebo plus trimethoprim-sulfamethoxazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures

  • Eradication of S. Aureus Colonization [ Time Frame: 30 days following completion of treatment ]
    Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
Secondary Outcome Measures:
  • Eradication of S. Aureus Colonization [ Time Frame: 7 days following completion of treatment ]
    Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
  • Eradication of S. Aureus Colonization [ Time Frame: 60 days following completion of treatment ]
    Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
  • Recurrent Skin and Skin Structure Infections (SSTI) [ Time Frame: up to 30 days following completion of treatment ]
    recurrent SSTI was by self-report and exam, followed until positive colonization

Enrollment: 12
Study Start Date: July 2009
Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Rifabutin
Subjects will be assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
Drug: rifabutin plus trimethoprim sulfamethoxazole

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

Placebo Comparator: Placebo
Subjects will be assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
Drug: placebo plus trimethoprim-sulfamethoxazole

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Age > 18 years
    2. HIV infection as reported by the subject's physician
    3. Physician-reported SSSI within the prior 6 months.
    4. 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.
    5. 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:
    1. Female subjects who are pregnant or lactating.
    2. Known or suspected hypersensitivity to rifabutin, a rifamycin class antimicrobial, TMP-SMX or another sulfa based medication.
    3. Known or suspected condition or concurrent treatment that would be contraindicated by the prescribing of rifabutin or TMP-SMX.
    4. 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).
    5. Diagnosis of an active SSSI or other signs and symptoms of S. aureus infection at the time of study enrollment
    6. Physician-reported diagnosis of active or untreated latent mycobacterial infection
    7. CrCl < 30 ml/min as determined by the Cockcroft-Gault Method using a serum creatinine from a value obtained within the last 6 months.
    8. No serum creatinine value available for the subject in the SFGH clinical laboratory system (LCR) within 6 months prior to enrollment.
    9. Physician-reported diagnosis of end-stage liver disease
    10. Physician-reported diagnosis of uveitis in the past or at time of enrollment
    11. 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)
    12. Colonizing S. aureus isolate resistant to TMP-SMX
    13. Colonizing S. aureus isolate resistant to rifampin (rifampin resistance will serve as a surrogate for rifabutin resistance at initial screening)
    14. Subjects who are unlikely to be able to comply with the mandated study visits

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869518

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Henry F Chambers, MD University of Califronia, San Francisco
Principal Investigator: Brian S Schwartz, MD University of California, San Francisco
More Information

More Information


Responsible Party: University of California, San Francisco  
ClinicalTrials.gov Identifier: NCT00869518   History of Changes  
Other Study ID Numbers: 08033578  
Study First Received: March 24, 2009  
Last Updated: April 23, 2014  

Keywords provided by University of California, San Francisco:

Staphylococcus aureus
colonization
eradication
HIV
rifabutin

Additional relevant MeSH terms:
Infection
HIV Infections
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Sulfamethoxazole
Rifabutin

ClinicalTrials.gov processed this data on December 11, 2017
This information is provided by ClinicalTrials.gov.