Clinical trial NCT01801618: National Evaluation of PI-based 2nd Line Efficacy in Cambodia
Official title: National Evaluation of PI-based 2nd Line Efficacy in Cambodia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
PI based 2nd line ARV treatment
Virological failure
Drug resistance
Cambodia
Adherence
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2013-03-01
Enrollment: 15001351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All HIV-1 infected adults receiving a PI-based 2nd line regimen in one of the 13 participating national program ARV treatment sites.

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.


Eligibility 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

Primary outcomes:
measure: Prevalence of virological failure
timeFrame: at month 4
measure: Prevalence of drug resistance
timeFrame: at inclusion
Secondary outcomes:
measure: Evaluation of individual risk factors associated with treatment failure
timeFrame: at inclusion
measure: Evaluation of structural risk factors associated with treatment failure
timeFrame: At study initiation
Other outcomes:
Locations:
city: Battambang
country: Cambodia
facility: Battambang Hospital
city: Chey Chum Neah
country: Cambodia
facility: Chey Chum Neah Hospital
city: Daun Keo
country: Cambodia
facility: Daun Keo Hospital
city: Kampong Cham
country: Cambodia
facility: Kampong Cham Hospital
city: Neak Loeung
country: Cambodia
facility: Neak Loeung Hospital
city: Phnom Penh
country: Cambodia
facility: Calmette Hospital
city: Phnom Penh
country: Cambodia
facility: Hope Center
city: Phnom Penh
country: Cambodia
facility: Khmero-Soviet Friendship Hospital
city: Phnom Penh
country: Cambodia
facility: Preah Kossamak Hospital
city: Phnom Penh
country: Cambodia
facility: Preahketomealea Hospital
city: Phnom Penh
country: Cambodia
facility: Social Health Clinic
city: Siem Reap
country: Cambodia
facility: Siem Reap Hospital
city: Sihanouk Ville
country: Cambodia
facility: Sihanouk Ville Hospital
Study officials:
affiliation: Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS)
name: Vonthanak Saphonn, MD
role: STUDY_CHAIR
affiliation: Institut Pasteur, Paris France
name: Eric Nerrienet, MD
role: STUDY_CHAIR
affiliation: Observatoire Régional de la Santé, Marseille, France
name: Bruno Spire, MD
role: STUDY_CHAIR
References: