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NCT00869518 · ClinicalTrials.gov registry record · Phase 2
Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00869518 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 12 participants.
The verdict
NCT00869518, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG rifabutin plus trimethoprim sulfamethoxazole
- DRUG placebo plus trimethoprim-sulfamethoxazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00869518
The ClinicalTrials.gov registry entry for NCT00869518 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which rifabutin plus trimethoprim sulfamethoxazole is the first listed.
NCT00869518 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00869518 about?
NCT00869518 is a clinical study titled "Rifabutin Based Therapy for the Eradication of Staphylococcus Aureus Colonization in HIV Infected Adults". 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 prio...
What is the current status of trial NCT00869518?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2009-07. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00869518?
The interventions under investigation include: rifabutin plus trimethoprim sulfamethoxazole (DRUG), placebo plus trimethoprim-sulfamethoxazole (DRUG).
Who is sponsoring clinical trial NCT00869518?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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