A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV (OPTI-NNRTI)
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ClinicalTrials.gov Identifier: NCT00523458 |
Recruitment Status
:
Terminated
(A delay in protocol approval and approval of laboratory sites in Salvador, Brazil left too little time for completion of enrollment into the study.)
First Posted
: August 31, 2007
Last Update Posted
: July 22, 2011
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Sponsor:
Stanford University
Information provided by:
Stanford University
Tracking Information | ||||
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First Submitted Date ICMJE | August 29, 2007 | |||
First Posted Date ICMJE | August 31, 2007 | |||
Last Update Posted Date | July 22, 2011 | |||
Study Start Date ICMJE | July 2007 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Decline in HIV RNA in plasma Rise in CD4 cell count [ Time Frame: Baseline, and Weeks 8, 20 and 32 ] These laboratory measures would be used to determine if there was a difference in the ARV failure rate between patients receiving standard dose vs high dose treatment with NNRTIs
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Original Primary Outcome Measures ICMJE |
Decline in HIV RNA in plasma Rise in CD4 cell count | |||
Change History | Complete list of historical versions of study NCT00523458 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments. | |||
Detailed Description | This is an open label, randomized study with 4 arms: 1.) Standard dose and 2.) high dose nevirapine; and 3.) standard dose and 4.) high dose efavirenz. Subjects in all 4 arms will also receive 2 nucleoside analog drugs. Patients will have routine monitoring for the treatment of TB and HIV, as well as some additional blood samples to follow the virus in the blood and to determine the effect of the TB therapy on the amounts of anti-HIV drugs that are in the body. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: efavirenz or nevirapine
Patients co-infected with HIV and TB will receive either "standard" doses of nevirapine (200 mg 2x daily) or efavirenz (600 mg daily) or "high" doses of nevirapine (400 mg and 200 mg daily) or efavirenz (800 mg daily) that are chosen to compensate for the change in pharmacokinetics shown to occur when co-infected patients are treated with the antituberculous drug, rifampin.
Other Names:
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
5 | |||
Original Estimated Enrollment ICMJE |
240 | |||
Actual Study Completion Date | March 2008 | |||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00523458 | |||
Other Study ID Numbers ICMJE | Stanford Protocol ID: 95564 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Terrence F Blaschke, Principle Investigator, Stanford University School of Medicine | |||
Study Sponsor ICMJE | Stanford University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Stanford University | |||
Verification Date | July 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |