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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All HIV-1 infected adults receiving a PI-based 2nd line regimen in one of the 13 participating national program ARV treatment sites.
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Battambang Hospital | Battambang | Cambodia | ||||
| Chey Chum Neah Hospital |
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Plasma HIV RNA and cDNA
| 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 |
| Chey Chum Neah |
| Cambodia |
| Daun Keo Hospital | Daun Keo | Cambodia |
| Kampong Cham Hospital | Kampong Cham | Cambodia |
| Neak Loeung Hospital | Neak Loeung | Cambodia |
| Calmette Hospital | Phnom Penh | Cambodia |
| Hope Center | Phnom Penh | Cambodia |
| Khmero-Soviet Friendship Hospital | Phnom Penh | Cambodia |
| Preah Kossamak Hospital | Phnom Penh | Cambodia |
| Preahketomealea Hospital | Phnom Penh | Cambodia |
| Social Health Clinic | Phnom Penh | Cambodia |
| Siem Reap Hospital | Siem Reap | Cambodia |
| Sihanouk Ville Hospital | Sihanoukville | Cambodia |