HIVNCT01801618
National Evaluation of PI-based 2nd Line Efficacy in Cambodia
An observational study of HIV, run by ANRS, Emerging Infectious Diseases at 13 sites in Cambodia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 15,001,351 participants
- Where
- 13 sitesCambodia
- Study dates
- Feb 2013to Dec 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- HIV infection
- age above 18 years
- current PI based 2nd line ARV treatment since at least 6 months
- willing to participate and consent signature
Who cannot join
- ongoing PI based 2nd line regimen for less that 6 months at time of study intake
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Cambodia13 sites
Battambang Hospital
Battambang
Chey Chum Neah Hospital
Chey Chum Neah
Daun Keo Hospital
Daun Keo
Kampong Cham Hospital
Kampong Cham
Neak Loeung Hospital
Neak Loeung
Calmette Hospital
Phnom Penh
Hope Center
Phnom Penh
Khmero-Soviet Friendship Hospital
Phnom Penh
Preah Kossamak Hospital
Phnom Penh
Preahketomealea Hospital
Phnom Penh
Social Health Clinic
Phnom Penh
Siem Reap Hospital
Siem Reap
Sihanouk Ville Hospital
Sihanoukville
About this study
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.
- Conditions
- HIV
- Keywords
- HIV, PI based 2nd line ARV treatment, Virological failure, Drug resistance, Cambodia, Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of virological failure
Virological failure is defined as an HIV viral load above 250 copies/mL
Measured: 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.
Measured: at inclusion
Secondary outcomes (2)
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.
Measured: at inclusion
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.
Measured: At study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 15,001,351 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vonthanak Saphonn, MD, Study chair, Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS)Eric Nerrienet, MD, Study chair, Institut Pasteur, Paris FranceBruno Spire, MD, Study chair, Observatoire Régional de la Santé, Marseille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801618
- Sponsor's protocol ID
- ANRS12276 2PICAM
- Status last verified
- Jul 2016
- First submitted
- 22 Feb 2013
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Evaluation of PI-based 2nd Line Efficacy in Cambodia
- ClinicalTrials.gov ID
- NCT01801618
- Acronym / sponsor ID
- ANRS12276 2PICAM
- Conditions
- HIV
- Keywords
- HIV, PI based 2nd line ARV treatment, Virological failure, Drug resistance, Cambodia, Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,001,351 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- HIV infection
- age above 18 years
- current PI based 2nd line ARV treatment since at least 6 months
- willing to participate and consent signature
Key exclusion criteria (1 listed)
- ongoing PI based 2nd line regimen for less that 6 months at time of study intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of virological failure
Time frame: at month 4
Virological failure is defined as an HIV viral load above 250 copies/mL
Prevalence of drug resistance
Time frame: 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.
2 secondary outcomes
Evaluation of individual risk factors associated with treatment failure
Time frame: at inclusion
Evaluation of structural risk factors associated with treatment failure
Time frame: At study initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vonthanak Saphonn, MD study chair
Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS)
Eric Nerrienet, MD study chair
Institut Pasteur, Paris France
Bruno Spire, MD study chair
Observatoire Régional de la Santé, Marseille, France
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by ANRS, Emerging Infectious Diseases at 13 sites in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of virological failure (time frame: at month 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.