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

This study has been terminated.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00869518
First received: March 24, 2009
Last updated: March 13, 2014
Last verified: March 2014

March 24, 2009
March 13, 2014
July 2009
December 2010   (final data collection date for primary outcome measure)
Eradication of S. Aureus Colonization [ Time Frame: 30 days following completion of treatment ] [ Designated as safety issue: No ]
Eradication was measured by performing cultures for S aureus at the nose, throat, and groin
Eradication of S. aureus colonization [ Time Frame: 30 days following completion of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00869518 on ClinicalTrials.gov Archive Site
  • Eradication of S. Aureus Colonization [ Time Frame: 7 days following completion of treatment ] [ Designated as safety issue: No ]
  • Eradication of S. Aureus Colonization [ Time Frame: 60 days following completion of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    recurrent SSTI was by self-report and exam, followed until positive colonization
  • Eradication of S. aureus colonization [ Time Frame: 7 days following completion of treatment ] [ Designated as safety issue: No ]
  • Eradication of S. aureus colonization [ Time Frame: 60 days following completion of treatment ] [ Designated as safety issue: No ]
  • Recurrent skin and skin structure infections [ Time Frame: 60 days following completion of treatment ] [ Designated as safety issue: No ]
  • Safety and tolerability profile of rifabutin plus TMP-SMX [ Time Frame: 60 days following completion of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Staphylococcus Aureus
  • HIV Infections
  • 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
  • Drug: placebo plus trimethoprim-sulfamethoxazole
    placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days
  • Active Comparator: Rifabutin
    Subjects will be assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole
    Intervention: Drug: rifabutin plus trimethoprim sulfamethoxazole
  • Placebo Comparator: Placebo
    Subjects will be assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole
    Intervention: Drug: placebo plus trimethoprim-sulfamethoxazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00869518
08033578
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Henry F Chambers, MD University of Califronia, San Francisco
Principal Investigator: Brian S Schwartz, MD University of California, San Francisco
University of California, San Francisco
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP