Trial record 17 of 27 for:    " March 18, 2009":" April 17, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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: April 23, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ 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: 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


Enrollment: 12
Study Start Date: July 2009
Study Completion Date: December 2010
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Results First Received: March 13, 2014
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Staphylococcus aureus
colonization
eradication
HIV
rifabutin

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Staphylococcal Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Rifabutin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014