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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Battambang Hospital, Battambang, Cambodia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Prevalence of virological failure

Time frame: at month 4

Virological failure is defined as an HIV viral load above 250 copies/mL
Prevalence of drug resistance

Time frame: at inclusion

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 outcomes

Evaluation of individual risk factors associated with treatment failure

Time frame: at inclusion

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

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.

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Mar 1, 2013
Registry last updated: Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed