A 72-week Randomized Clinical Trial Comparing the Safety and Efficacy of Three Initial Antiretroviral Regimens -GPO-VIR S (d4T/3TC/NVP) for 24 Weeks Followed by GPO-VIR Z (AZT/3TC/NVP) vs GPO-VIR Z vs TDF/FTC/NVP
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First Received Date ICMJE | April 24, 2008 | ||||||||
Last Updated Date | May 4, 2011 | ||||||||
Start Date ICMJE | April 2008 | ||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
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Change History | Complete list of historical versions of study NCT00669487 on ClinicalTrials.gov Archive Site | ||||||||
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Descriptive Information | |||||||||
Brief Title ICMJE | A 72-week Randomized Clinical Trial Comparing the Safety and Efficacy of Three Initial Antiretroviral Regimens -GPO-VIR S (d4T/3TC/NVP) for 24 Weeks Followed by GPO-VIR Z (AZT/3TC/NVP) vs GPO-VIR Z vs TDF/FTC/NVP | ||||||||
Official Title ICMJE | |||||||||
Brief Summary | This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function. |
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Detailed Description | GPO-VIR Z is a new combination antiretroviral (ARV) medication that substitutes zidovudine (AZT) for stavudine (d4T) from the original formulation of GPO-VIR S. This new combination should decrease rates of lipoatrophy and neuropathy which are side-effects strongly linked to the use of d4T. However, there is some risk that initiating therapy with an AZT- containing regimen may cause unacceptable rates of anemia. Many Thai physicians have adopted a practice of using 6 months of the stavudine-containing GPO-VIR S as a lead in before introducing AZT-containing GPO-VIR Z in an effort to balance the risks and benefits of these two medications. There are no definitive data, however, that can attest to the benefit of such an approach. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* 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 | ||||||||
Estimated Enrollment ICMJE | 150 | ||||||||
Completion Date | April 2011 | ||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | Thailand | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00669487 | ||||||||
Other Study ID Numbers ICMJE | SEARCH003 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Nitiya Chomchey, SEARCH Thailand | ||||||||
Study Sponsor ICMJE | South East Asia Research Collaboration with Hawaii | ||||||||
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Information Provided By | South East Asia Research Collaboration with Hawaii | ||||||||
Verification Date | July 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |