National Evaluation of PI-based 2nd Line Efficacy in Cambodia

This study is currently recruiting participants.
Verified February 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01801618
First received: February 22, 2013
Last updated: February 28, 2013
Last verified: February 2013

February 22, 2013
February 28, 2013
February 2013
May 2014   (final data collection date for primary outcome measure)
  • Prevalence of virological failure [ Time Frame: at month 4 ] [ Designated as safety issue: No ]
    Virological failure is defined as an HIV viral load above 250 copies/mL
  • Prevalence of drug resistance [ Time Frame: at inclusion ] [ Designated as safety issue: No ]

    Sequencing of reverse transcriptase (RT), protease (PR) and integrase (IN) HIV genes.

    HIV drug resistance is defined by the presence of resistance associated mutations inducing resistance according to the ANRS algorithm to one or more drugs in the standard second line regimen(s) used in Cambodia.

Same as current
Complete list of historical versions of study NCT01801618 on ClinicalTrials.gov Archive Site
  • Evaluation of individual risk factors associated with treatment failure [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
    Individual factors will be collected at enrolment by a standardized questionnaire administered during a face to face 20 minutes interview by a trained member of the healthcare team. The questionnaire investigate adherence, perception of side effect, socio-economic status, disclosure and discrimination issues.
  • Evaluation of structural risk factors associated with treatment failure [ Time Frame: At study initiation ] [ Designated as safety issue: No ]
    Structural risk factors will be collected at the beginning of the study in each participating site through a standardized questionnaire including information on episodes of ARV stock-outs, task-shifting of HIV-care from physician to nurses, availability of psychosocial support, health service provider/patient ratio and health care provider availabilities, quality control, site activities indicators. The questionaire will be filled by the site project coordinator together with the coordinating project social science team.
Same as current
Not Provided
Not Provided
 
National Evaluation of PI-based 2nd Line Efficacy in Cambodia
National Evaluation of PI-based 2nd Line Efficacy in Cambodia

Medium and long term efficacy of PI-based 2nd line antiretroviral (ARV) therapy in Cambodia is poorly documented when the numbers of patients on treatment and their duration are increasing. For patients in treatment failure , there is no alternative ARV regimen available to date.

This operational research aims to evaluate the Cambodian National Program PI-based 2nd line antiretroviral regimen to assess the proportion of treatment failure and drug resistance ;identify the structural and individual factors associated with treatment failure ; design alternative salvage ARV regimens.

Not Provided
Observational [Patient Registry]
Time Perspective: Cross-Sectional
6 Months
Retention:   Samples With DNA
Description:

Plasma HIV RNA and cDNA

Non-Probability Sample

All HIV-1 infected adults receiving a PI-based 2nd line regimen in one of the 13 participating national program ARV treatment sites.

HIV
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
August 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection
  • age above 18 years
  • current PI based 2nd line ARV treatment since at least 6 months
  • willing to participate and consent signature

Exclusion Criteria:

  • ongoing PI based 2nd line regimen for less that 6 months at time of study intake
Both
18 Years and older
No
Contact: Vonthanak Saphonn, MD +855 12 280 790 vonthanak@univ-sante.edu.kh
Cambodia
 
NCT01801618
ANRS12276 2PICAM
No
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Study Chair: Vonthanak Saphonn, MD Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS)
Study Chair: Eric Nerrienet, MD Institut Pasteur, Paris, France
Study Chair: Bruno Spire, MD Observatoire Régional de la Santé, Marseille, France
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP