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

Completed

• Conditions: HIV

• Registration Number: NCT01801618
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15001351

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of virological failure	at month 4	Virological failure is defined as an HIV viral load above 250 copies/mL
Prevalence of drug resistance	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 Outcome Measures

Name	Time	Method
Evaluation of individual risk factors associated with treatment failure	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	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.

Trial Locations

Locations (13)

Hope Center; 🇰🇭 Phnom Penh, Cambodia

Calmette Hospital; 🇰🇭 Phnom Penh, Cambodia

Chey Chum Neah Hospital; 🇰🇭 Chey Chum Neah, Cambodia

Daun Keo Hospital; 🇰🇭 Daun Keo, Cambodia

Preah Kossamak Hospital; 🇰🇭 Phnom Penh, Cambodia

Social Health Clinic; 🇰🇭 Phnom Penh, Cambodia

Siem Reap Hospital; 🇰🇭 Siem Reap, Cambodia

Battambang Hospital; 🇰🇭 Battambang, Cambodia

Kampong Cham Hospital; 🇰🇭 Kampong Cham, Cambodia

Neak Loeung Hospital; 🇰🇭 Neak Loeung, Cambodia

Khmero-Soviet Friendship Hospital; 🇰🇭 Phnom Penh, Cambodia

Sihanouk Ville Hospital; 🇰🇭 Sihanouk Ville, Cambodia

Preahketomealea Hospital; 🇰🇭 Phnom Penh, Cambodia