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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug resistance, PI based 2nd line ARV treatment, Virological failure, Cambodia, Adherence, HIV