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.

Study Overview

• Status: Completed
• Conditions: HIV

• Study Type: Observational
• Enrollment (Actual): 15001351

Contacts and Locations

Study Locations

• Cambodia
  • Battambang, Cambodia
    • Battambang Hospital
  • Chey Chum Neah, Cambodia
    • Chey Chum Neah Hospital
  • Daun Keo, Cambodia
    • Daun Keo Hospital
  • Kampong Cham, Cambodia
    • Kampong Cham Hospital
  • Neak Loeung, Cambodia
    • Neak Loeung Hospital
  • Phnom Penh, Cambodia
    • Calmette Hospital
  • Phnom Penh, 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
  • Siem Reap, Cambodia
    • Siem Reap Hospital
  • Sihanouk Ville, Cambodia
    • Sihanouk Ville Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of virological failure	Virological failure is defined as an HIV viral load above 250 copies/mL	at month 4
Prevalence of drug resistance	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.	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of individual risk factors associated with treatment failure	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.	at inclusion
Evaluation of structural risk factors associated with treatment failure	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.	At study initiation

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• 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

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Adherence; HIV; Drug resistance; Virological failure; Cambodia; PI based 2nd line ARV treatment
• Other Study ID Numbers: ANRS12276 2PICAM