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Sponsors and Collaborators: |
Institut de Recherche pour le Developpement National Institute of Child Health and Human Development (NICHD) Harvard School of Public Health |
Information provided by: | Institut de Recherche pour le Developpement |
ClinicalTrials.gov Identifier: | NCT00162682 |
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
Condition | Intervention | Phase |
HIV Infections |
Procedure: Antiretroviral Drug Combination Switching Criteria |
Phase III |
MedlinePlus related topics: | AIDS AIDS Medicines |
ChemIDplus related topics: | BaseLine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 716 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
* VL-S, the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.
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Procedure: Antiretroviral Drug Combination Switching Criteria
Antiretroviral treatment will use the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.
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2: Experimental
CD4-S, the alternative CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.
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Procedure: Antiretroviral Drug Combination Switching Criteria
Antiretroviral treatment is monitored using a CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Thailand | |||||
Buddhachinaraj Hospital | |||||
Bangkok, Thailand, 10220 | |||||
Chacheongsao Hospital | |||||
Chacheongsao, Thailand, 24000 | |||||
Regional Health Promotion Centre 6, | |||||
Khon Kaen, Thailand, 40000 | |||||
Rayong Hospital | |||||
Rayong, Thailand, 21000 | |||||
Samutprakarn Hospital | |||||
Samutprakarn, Thailand, 10280 | |||||
Thailand, Chantaburi | |||||
Prapokklao Hospital | |||||
Prapokklao, Muang, Chantaburi, Thailand, 22000 | |||||
Thailand, Chiang Mai | |||||
Nakornping Hospital | |||||
Mae Rim, Chiang Mai, Thailand, 50180 | |||||
Sanpatong Hospital | |||||
Sanpatong, Chiang Mai, Thailand, 50120 | |||||
Thailand, Chiang Rai | |||||
Mae Chan Hospital | |||||
Mae Chan, Chiang Rai, Thailand, 57110 | |||||
Thailand, Chiangrai | |||||
Chiangrai Prachanukroh Hospital | |||||
Muang, Chiangrai, Chiangrai, Thailand, 57000 | |||||
Thailand, Chonburi | |||||
Chonburi Hospital | |||||
Muang, Chonburi, Chonburi, Thailand, 20000 | |||||
Thailand, Lampang | |||||
Lampang Hospital | |||||
Muang, Lampang, Lampang, Thailand, 52000 | |||||
Thailand, Lamphun | |||||
Lamphun Hospital | |||||
Muang, Lamphun, Thailand, 51000 | |||||
Thailand, Mahasarakam | |||||
Mahasarakam Hospital | |||||
Muang, Mahasarakam, Thailand, 44000 | |||||
Thailand, Nakornratchasrima | |||||
Maharaj Nakornratchasrima Hospital | |||||
Muang, Nakornratchasrima, Nakornratchasrima, Thailand, 30000 | |||||
Thailand, Nong Khai | |||||
Nong Khai Hospital | |||||
Muang, Nong Khai, Nong Khai, Thailand, 43000 | |||||
Thailand, Phayao | |||||
Phayao Provincial Hospital | |||||
Muang, Phayao, Thailand, 56000 | |||||
Thailand, Ratchaburi | |||||
Ratchaburi Hospital | |||||
Muang, Ratchaburi, Ratchaburi, Thailand, 70000 | |||||
Thailand, Samutsakorn | |||||
Samutsakorn Hospital | |||||
Muang, Samutsakorn, Samutsakorn, Thailand, 74000 | |||||
Thailand, Songkla | |||||
Hat Yai Hospital | |||||
Hat Yai, Songkla, Thailand, 90110 |
Institut de Recherche pour le Developpement |
National Institute of Child Health and Human Development (NICHD) |
Harvard School of Public Health |
Principal Investigator: | Marc Lallemant, MD | Institut de Recherche pour le Developpement & Harvard School of Public Health |
Study ID Numbers: | R01-HD042964 |
First Received: | September 7, 2005 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00162682 |
Health Authority: | Thailand: Ministry of Public Health |
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