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HIV InfectionsNCT00690001

The Detection of Drug-Resistant HIV-1 in Taiwan

An observational study of HIV Infections, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
HIV Infections
How many people
150 participants
Where
1 siteTaiwan
Study dates
Apr 2008to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: HIV-1-infected patients under antiretroviral therapy with clinical suspicion of emergence of virus resistance

Who may be able to join

  • 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.

Who cannot join

  • with antiretroviral therapy within 4 weeks

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Szu-Min Hsieh, hsmaids@hotmail.com

    Szu-Min Hsieh, M.D.

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
HIV Infections
Keywords
HIV-1 infection, Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00690001
Study groupRoleWhat they receive
1HIV-1 infected patients in Taiwan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. genotypic resistance testing

    Measured: May 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2008 (estimated)
  2. Study startApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00690001
Sponsor's protocol ID
200803084R
Status last verified
Apr 2008
First submitted
1 Jun 2008
Last updated
8 Jul 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Szu-Min Hsieh, M.D. (886-2-2312-3456 ext. 7831, hsmaids@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

genotypic resistance testing (time frame: May 2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2008.

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