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Genotypic Resistant HIV Strains 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: NCT00954863
Recruitment Status : Unknown
Verified August 2009 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 7, 2009
Last Update Posted : September 29, 2009
Information provided by:
National Taiwan University Hospital

Brief Summary:

Based on the investigators previous study, seventy-four of 786 HIV-1 isolates (9.4%), collected between 1999 to 2006, harbored one or more primary mutations associated with antiretroviral resistance to reverse-transcriptase inhibitors (RTIs) or protease inhibitors (PIs) in naïve patients. However, the drug resistance profiles for the HIV-1 integrase gene is unclear. Three objectives are proposed:

  1. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene between experienced and naive patients, who has not being exposed to Raltegravir.
  2. To investigate and compare the drug resistance profiles for the HIV-1 integrase gene between different subtypes (subtype B, CRF01_AE and CRF07_BC).
  3. To identify potential amino acid mutations in the integrase gene, which might affect the efficacy of Raltegravir.

Condition or disease
HIV-1 HIV Infections

Detailed Description:

From 2008 to 2009, blood samples will be collected from consecutive HIV-1-infected patients who received HIV care at the National Taiwan University Hospital. We expect to collect 100 cases who are antiretroviral naïve and 100 cases who are treatment-experienced patients. A standardized case collection form will be used to record data of demographics and clinical characteristics and laboratory results, such as plasma HIV RNA load (PVL) and CD4 cell counts. PVL will be quantified by the Cobas Amplicor HIV-1 MonitorTM Test, version 1.5, (Roche Diagnostics Corporation, Indianapolis, USA) according to manufacturer's protocol. The CD4 cell count will be determined using FACSFlow (Becton Dickinson). This study was approved by the Institutional Review Board of the hospital.

The in-house genotypic drug resistance test will be performed to determine the drug resistance profiles for the HIV-1 pol gene, focusing on protease, reverse transcriptase, and integrase. Drug resistance mutations will be identified with the use of the HIVdb program of the Stanford University HIV Drug Resistance Database (, in accordance with the drug-resistance mutation list of the International AIDS Society-USA Consensus Guidelines [24]. Strains with genetic mixtures of wild-type and mutant sequences at amino acid residues that code for major drug resistance will be considered to be drug resistant. Based on the interpretation given by the HIVdb program, sequences will be divided into the drug-resistant sequences, interpreted as having high, intermediate, and low levels of resistance, and the sensitive sequences, interpreted as the sensitive and potentially resistant. Multi-drug resistance (MDR) will be defined as having genotypic resistance to more than one class of antiretroviral drugs. Reference sequences of various subtypes and recombinants will be retrieved from the Los Alamos database ( Sequences will be aligned with the Clustal W listed in the MEGA (molecular evolutionary genetics analysis) analytical package (version 3.0) [25] with minor manual adjustments. The phylogenetic trees will be constructed by the neighbor-joining method based on the Kimura 2-parameter distance matrix listed in the MEGA software. Bootstrap values greater than 750 of 1,000 replicates are considered significant.

The phenotype of those with specific or unique amino acid mutation at integrase gene will be determined using in-house phenotypic assay. Briefly, the p7 to vif fragment, about 3.6kb, will be amplified from patients' plasma viral RNA and cloned into our backbone viral clone (Figure 1). The resultant clones will be transfected into 293 cells to produce infectious viruses, whose titers will be determined by p24 assay and equal amounts of viruses will be subsequently used to infect PBMC from healthy donors. Virus titers in the supernatants from infected cells after 3, 5, and 7 days post infection in the presence or absence of tested compounds will be determined by real-time PCR or p24 assay. The minimal concentration of compounds required to reduce 50% of supernatant viral copies (EC50) will be calculated by regression analysis of the dose-response curves generated from real-time PCR or p24 assay.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification and Characterization of Genotypic Resistant HIV Strains in Taiwan
Study Start Date : August 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected individuals receiving clinical care at National Taiwan University Hospital

Inclusion Criteria:

  • HIV-infected individuals

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954863

Contact: Sui-Yuan Chang, Sc. D. 886-2-23123456 ext 66908

R424, Examination Building, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Sui-Yuan Chang, Sc. D.    886-2-23123456 ext 66908   
Principal Investigator: Sui-Yuan Chang, Sc. D.         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Sui-Yuan Chang, Sc. D. National Taiwan University

Additional Information:
Responsible Party: Sui-Yuan Chang/Assistant professor, National Taiwan University Identifier: NCT00954863     History of Changes
Other Study ID Numbers: 200905045R
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: September 29, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases