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

This study has been completed.
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: July 20, 2016
Last verified: July 2016
  Purpose

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.


Condition
HIV

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: National Evaluation of PI-based 2nd Line Efficacy in Cambodia

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Plasma HIV RNA and cDNA

Enrollment: 15001351
Study Start Date: February 2013
Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All HIV-1 infected adults receiving a PI-based 2nd line regimen in one of the 13 participating national program ARV treatment sites.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801618

Locations
Cambodia
Battambang Hospital
Battambang, Cambodia
Chey Chum Neah Hospital
Chey Chum Neah, Cambodia
Daun Keo Hospital
Daun Keo, Cambodia
Kampong Cham Hospital
Kampong Cham, Cambodia
Neak Loeung Hospital
Neak Loeung, Cambodia
Khmero-Soviet Friendship Hospital
Phnom Penh, Cambodia
Hope Center
Phnom Penh, Cambodia
Preah Kossamak Hospital
Phnom Penh, Cambodia
Preahketomealea Hospital
Phnom Penh, Cambodia
Social Health Clinic
Phnom Penh, Cambodia
Calmette Hospital
Phnom Penh, Cambodia
Siem Reap Hospital
Siem Reap, Cambodia
Sihanouk Ville Hospital
Sihanouk Ville, Cambodia
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
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
  More Information

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     History of Changes
Other Study ID Numbers: ANRS12276 2PICAM 
Study First Received: February 22, 2013
Last Updated: July 20, 2016
Health Authority: Cambodia: Ministry of Health

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV
PI based 2nd line ARV treatment
Virological failure
Drug resistance
Cambodia
Adherence

ClinicalTrials.gov processed this record on July 26, 2016