Monitoring Highly Active Antiretroviral Therapy in HIV-infected Parents in Thailand
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ClinicalTrials.gov Identifier: NCT00162682 |
Recruitment Status :
Completed
First Posted : September 13, 2005
Last Update Posted : January 6, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | September 7, 2005 | |||
First Posted Date ICMJE | September 13, 2005 | |||
Last Update Posted Date | January 6, 2012 | |||
Study Start Date ICMJE | May 2005 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Proportion of "clinical failures" defined as confirmed CD4 count below 50/mm3, first or new AIDS-defining event, or death [ Time Frame: After 3 years of follow-up ] | |||
Original Primary Outcome Measures ICMJE |
Proportion of "clinical failures" defined as confirmed CD4 count below 50/mm3, first or new AIDS-defining event, or death | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
The number of therapeutic options left taking into account drugs exhausted cross-resistance mutations and shared toxicities | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Monitoring Highly Active Antiretroviral Therapy in HIV-infected Parents in Thailand | |||
Official Title ICMJE | A Phase III, Randomized, Non-inferiority Trial Comparing the Standard Viral Load Based Antiretroviral Monitoring Strategy With a CD4 Based Monitoring Strategy Among Antiretroviral Naive Immunocompromised Adults in Thailand | |||
Brief Summary | The purpose of this study is to determine if a decision to switch to a subsequent antiretroviral regimen based upon the CD4 cell count rather than the standard switching strategy based on viral load could ensure the same immunological and clinical outcome and preserve future treatment options in AIDS patients | |||
Detailed Description | Implementation of highly active antiretroviral therapy (HAART) has led to a substantial decrease in HIV-related mortality and morbidity. Current guidelines emphasize maximal and durable viral load suppression. However, while the goal of therapy is the restoration of immunity, treatment failure is usually defined as the inability to maintain undetectable viral load, without regard to immune function. This situation often leads to a rapid sequence of therapeutic switches, thus narrowing therapeutic options over time. A monitoring strategy driven primarily by the patient's immune restoration would most likely be as effective in preventing disease progression, would lead to fewer changes in HAART regimens and would be considerably simpler and cost effective. Subjects will be randomly assigned to one of two switching strategies:
The initial HAART regimen will be a NNRTI+NRTI containing regimen and the second line regimen will be a PI containing regimen, subsequent regimens will be chosen individually based on tolerance, previous drugs used, resistance profile, and drugs available. Patients will be followed until the end of the study (maximum of 5 years for the first enrollee, three years for the last enrollee). |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | Completed | |||
Actual Enrollment ICMJE |
716 | |||
Original Enrollment ICMJE |
700 | |||
Actual Study Completion Date ICMJE | December 2011 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Eligibility Criteria: Patients fulfilling the following criteria are eligible:
Inclusion Criteria: Eligible patients fulfilling the following criteria can be enrolled in the study:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Thailand | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00162682 | |||
Other Study ID Numbers ICMJE | R01HD042964( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Marc Lallemant, Institut de Recherche pour le Developpement | |||
Study Sponsor ICMJE | Institut de Recherche pour le Developpement | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Institut de Recherche pour le Developpement | |||
Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |