NCT00690001

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
Last Updated

July 8, 2008

Status Verified

April 1, 2008

First QC Date

June 1, 2008

Last Update Submit

July 7, 2008

Conditions

HIV Infections

Keywords

HIV-1 infectionTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • genotypic resistance testing

    May 2009

Study Arms (1)

1

HIV-1 infected patients in Taiwan

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • with antiretroviral therapy within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Szu-Min Hsieh, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Szu-Min Hsieh, M.D.

CONTACT

886-2-2312-3456hsmaids@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2008

First Posted

June 4, 2008

Study Start

April 1, 2008

Last Updated

July 8, 2008

Record last verified: 2008-04

Locations

TW(1)