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The Detection of Drug-Resistant HIV-1 in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00690001
Recruitment Status : Unknown
Verified April 2008 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 4, 2008
Last Update Posted : July 8, 2008
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date June 1, 2008
First Posted Date June 4, 2008
Last Update Posted Date July 8, 2008
Study Start Date April 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: June 3, 2008)
genotypic resistance testing [ Time Frame: May 2009 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00690001 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title The Detection of Drug-Resistant HIV-1 in Taiwan
Official Title The Detection of Drug-Resistant HIV-1 in Taiwan
Brief Summary To assess the HIV resistance rate to variable antiretroviral agents in Taiwan, especially in patients with treatment failure, and to know the correlation between the drug resistance pattern and the HIV subtype, we will enroll a total of 150~200 HIV-1-infected subjects to perform genotypic resistance testing and try to establish facility of phenotypic resistance testing.
Detailed Description

Drug-resistant HIV strains may develop during antiretroviral therapy, and transmission of drug-resistant virus has been documented to be possible. The emergence of drug resistance in HIV has been associated with suboptimal virologic response to antiretroviral therapy [1]. The likelihood that a patient will acquire drug-resistant virus is related to the prevalence of drug resistance in the population with specific high-risk behaviors. In the western countries, studies suggest that the prevalence of viral resistance to at least one antiretroviral drug ranges from 6% to 16% in treatment-naïve patients, and among them, about 3% to 5% with reduced susceptibility to more than one class [2-4]. However, there is no data addressing the prevalence of drug resistance in various populations in Taiwan currently.

Drug resistance can be measured using either genotypic or phenotypic resistance assays. Genotypic assays detect mutations that cause dug resistance; phenotypic assays are drug susceptibility assays that measuring the in vitro ability of the virus to grow in the presence of serial dilutions of the inhibitors (that is, antiretroviral drugs). Because of its more rapid turnaround time and less expensiveness, a genotypic assay is generally preferred to phenotypic assay [5]. Genotypic resistance assay has been available in three AIDS centers in Taiwan. However, the methods used for genotypic assay are different in the three centers, and these data have not been gathered and analyzed to know the epidemiology of HIV resistance in Taiwan, thus the interpretation and application of the results from genotypic resistance assay for selection of antiretrovirals are quite questionable in Taiwan.

Furthermore, though the genotypic assay is less straightforward, several conditions exist to cause the discordance between genotype and phenotype, and the discordance may result in the difficulty in phenotype prediction from genotype [6]. Thus, phenotypic assay may help interpretation of resistance testing results and provide a guide to decide the optimal regimen. With the availability of newer classes of antiretrovirals in the near future, currently commercially available phenotypic testing using the recombinant viruses with insertion of reverse transcriptase and protease gene sequences may not be enough. A new phenotypic assay that can measure the virus ability to grow in the different concentrations of NRTIs, NNRTIs, PIs, entry inhibitors, CCR5 inhibitors and integrase inhibitors will be needed.

It has been known that HIV-1 load in plasma is strongly correlated with disease progression, response to antiviral treatment, and transmission from mother to child. The plasma viral RNA is more representative of the replicating virus pool at any time point than the cell-associated proviral DNA. In order to study the relationship of the complete HIV-1 genome to phenotypic resistance, we choose to focus on plasma virions. However, for those patients whose plasma viral load is not high enough to conduct this analysis, we will instead of using patients' proviral DNA from infected PBMC for phenotypic resistance analysis. Two strategies will be used to amplify viral genome. The first one will be amplification of a nearly full-length viral genome. If this strategy does not work, the second strategy will be to amplify two fragments of viral genome and to assemble these two fragments by unique restriction enzymes.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HIV-1-infected patients under antiretroviral therapy with clinical suspicion of emergence of virus resistance
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts 1
HIV-1 infected patients in Taiwan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 3, 2008)
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • HIV-1-infected subjects under antiretroviral therapy if they are 20 ~ 60 years old and have a plasma HIV RNA > 1000 copies/mL and give inform consents will be enrolled.

Exclusion Criteria:

  • with antiretroviral therapy within 4 weeks
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
Administrative Information
NCT Number NCT00690001
Other Study ID Numbers 200803084R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Szu-Min Hsieh, National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Principal Investigator: Szu-Min Hsieh, M.D. National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date April 2008