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Sponsors and Collaborators: |
University Health Network, Toronto Canadian Institutes of Health Research (CIHR) Canadian HIV Trials Network |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188851 |
The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response.
Condition | Intervention |
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HIV |
Drug: therapeutic management strategy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective Randomized Trial of Structured Treatment Interruption(STI) Followed by Initiation of a New Antiretroviral Regimen(ARV) Versus Immediate Switching to a New ARV in HIV-Infected Patients Experiencing Virologic Failure on HAART |
Estimated Enrollment: | 196 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | November 2005 |
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis: By withdrawing ARV drug pressure, resistant HIV virus will revert to wild-type. In treatment-experienced HIV patients who experience virologic failure, a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime.
Interventions:
Immediate Switch to Salvage Therapy: Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results.
Structured Treatment Interruption: Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Mona Loutfy, MD | University Health Network, Toronto, On |
Study Director: | Joel Singer, MD | Canadian Trials Network, Vancouver, B.C. |
Study Director: | Janet Raboud, Dr. | Univeristy Health Network, Toronto, On |
Study Director: | Stephen Shafran, MD | University of Alberta, Edmonton, Alberta |
Study Director: | Bill Cameron, MD | Ottawa Hospital, Ottawa, On |
Study Director: | Sylvie Trottier, MD | Clinique Medicale L'Actuel, Montreal, Quebec |
Study Director: | Richard Harrigan, MD | B.C. Centre of Excellence, Vancouver, B.C. |
Study ID Numbers: | CIHR82716 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00188851 |
Health Authority: | Canada: Health Canada |
HIV salvage regimen virologic failure treatment interruption ARV experienced |
HIV Infections Acquired Immunodeficiency Syndrome |