Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance
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ClinicalTrials.gov Identifier: NCT00120783 |
Recruitment Status
:
Terminated
First Posted
: July 19, 2005
Last Update Posted
: January 18, 2007
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Tracking Information | |||||||
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First Submitted Date ICMJE | July 12, 2005 | ||||||
First Posted Date ICMJE | July 19, 2005 | ||||||
Last Update Posted Date | January 18, 2007 | ||||||
Study Start Date ICMJE | February 2002 | ||||||
Primary Completion Date | Not Provided | ||||||
Current Primary Outcome Measures ICMJE |
Decrease over 25% in CD4 counts (immunological failure–IF), or increase over 0.7 log in plasma HIV RNA (virological failure–VF) at two consecutive monthly visits during the 24-week study | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00120783 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance | ||||||
Official Title ICMJE | Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial. | ||||||
Brief Summary | This study investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses. | ||||||
Detailed Description | In patients with HIV multidrug resistance, maintaining a failing full-dose HAART regimen usually results in significant drug toxicity and in continued accumulation of resistance mutations that can preclude future therapeutic options. In contrast, treatment interruption provokes the reemergence of wild-type virus with full replicative and pathogenic capacity. The researchers investigated whether a calibrated reduction in drug pressure could stabilize the evolution and the pathogenic potential of resistant virus. A prospective pilot study was conducted in patients receiving protease inhibitor-based HAART with a resistance genotype predicting less than two active drugs according to the 2002 ANRS algorithm, CD4 counts over or equal to 100/mm3 and plasma HIV RNA below or equal to 5 log/ml. The treatment was low-dose IDV/RTV (200/100 BID) and 3TC 150mg BID. IDV doses were adjusted at week 4 to ensure a Cmin of 250+/-100ng/ml, which, based on a panel of multi-PI resistant viruses, was calculated to yield an inhibitory quotient (Cmin/IC50) of 0.50. Primary end-points were over 25% decrease in CD4 counts (immunological failure–IF), or over 0.7 log increase in plasma HIV RNA (virological failure–VF) at two consecutive monthly visits during the 24-week study. Inclusions were to stop when the total number of failures (VF+IF) reached 7 |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | ||||||
Intervention ICMJE |
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Study Arms | Not Provided | ||||||
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 | ||||||
Enrollment ICMJE |
40 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date | August 2003 | ||||||
Primary Completion Date | Not Provided | ||||||
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 | France | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00120783 | ||||||
Other Study ID Numbers ICMJE | ANRS 109 VISTA | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | French National Agency for Research on AIDS and Viral Hepatitis | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | French National Agency for Research on AIDS and Viral Hepatitis | ||||||
Verification Date | January 2007 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |