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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801618
• Other study ID #: ANRS12276 2PICAM
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: July 20, 2016
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cambodia: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15001351
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
Cambodia	Battambang Hospital	Battambang
Cambodia	Chey Chum Neah Hospital	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	Sihanouk Ville

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of virological failure	Virological failure is defined as an HIV viral load above 250 copies/mL	at month 4	No
Primary	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	No
Secondary	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	No
Secondary	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	No