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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 August 2016
Main ID:  NCT01801618
Date of registration: 22/02/2013
Prospective Registration: No
Primary sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Public title: National Evaluation of PI-based 2nd Line Efficacy in Cambodia
Scientific title: National Evaluation of PI-based 2nd Line Efficacy in Cambodia
Date of first enrolment: February 2013
Target sample size: 15001351
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01801618
Study type:  Observational [Patient Registry]
Study design:  Time Perspective: Cross-Sectional  
Phase:  N/A
Countries of recruitment
Cambodia
Contacts
Name:     Bruno Spire, MD
Address: 
Telephone:
Email:
Affiliation:  Observatoire Régional de la Santé, Marseille, France
Name:     Eric Nerrienet, MD
Address: 
Telephone:
Email:
Affiliation:  Institut Pasteur, Paris, France
Name:     Vonthanak Saphonn, MD
Address: 
Telephone:
Email:
Affiliation:  Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS)
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
HIV
Intervention(s)
Primary Outcome(s)
Prevalence of drug resistance [Time Frame: at inclusion]
Prevalence of virological failure [Time Frame: at month 4]
Secondary Outcome(s)
Evaluation of structural risk factors associated with treatment failure [Time Frame: At study initiation]
Evaluation of individual risk factors associated with treatment failure [Time Frame: at inclusion]
Secondary ID(s)
ANRS12276 2PICAM
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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