NCT01801618|Completed
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Sponsor study identifier
observational
15,001,351
1 country
13
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 22, 2013
Actual (reported)March 1, 2013
Actual (reported)July 2014
Actual (reported)December 2014
Actual (reported)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
Evaluation of individual risk factors associated with treatment failure
at inclusion
Evaluation of structural risk factors associated with treatment failure
At study initiation
All HIV-1 infected adults receiving a PI-based 2nd line regimen in one of the 13 participating national program ARV treatment sites.
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
Plasma HIV RNA and cDNA
Vonthanak Saphonn, MD
Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS)
Eric Nerrienet, MD
Institut Pasteur, Paris France
Bruno Spire, MD
Observatoire Régional de la Santé, Marseille, France
15,001,351 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2013
First Posted
March 1, 2013
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Outcome at 5 Years of Early Treated HIV Infected Infants in the PEDIACAM Project
Contact the study team to confirm eligibility.
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
Primary Completion
July 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
July 21, 2016
Record last verified: 2016-07
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Source: ClinicalTrials.gov.
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