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

ANRS, Emerging Infectious Diseases15,001,351 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

15,001,351

Conditions

HIV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Battambang Hospital

Battambang, Cambodia

Chey Chum Neah Hospital

Chey Chum Neah, Cambodia

Daun Keo Hospital

Daun Keo, Cambodia

Outcomes

Primary Outcomes

Prevalence of virological failure

Virological failure is defined as an HIV viral load above 250 copies/mL

Time frame: 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.

Time frame: at inclusion

Secondary Outcomes

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.

Time frame: 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.

Time frame: At study initiation

Data from ClinicalTrials.gov

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