National Evaluation of PI-based 2nd Line Efficacy in Cambodia
This study is currently recruiting participants.
Verified February 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01801618
First received: February 22, 2013
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
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.
| Condition |
|---|
|
HIV |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Time Perspective: Cross-Sectional |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | National Evaluation of PI-based 2nd Line Efficacy in Cambodia |
Resource links provided by NLM:
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- Prevalence of virological failure [ Time Frame: at month 4 ] [ Designated as safety issue: No ]Virological failure is defined as an HIV viral load above 250 copies/mL
- Prevalence of drug resistance [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Evaluation of individual risk factors associated with treatment failure [ Time Frame: at inclusion ] [ Designated as safety issue: No ]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.
- Evaluation of structural risk factors associated with treatment failure [ Time Frame: At study initiation ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Plasma HIV RNA and cDNA
| Estimated Enrollment: | 1500 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801618
Contacts
| Contact: Vonthanak Saphonn, MD | +855 12 280 790 | vonthanak@univ-sante.edu.kh |
Locations
| Cambodia | |
| Battambang Hospital | Not yet recruiting |
| Battambang, Cambodia | |
| Chey Chum Neah Hospital | Recruiting |
| Chey Chum Neah, Cambodia | |
| Daun Keo Hospital | Not yet recruiting |
| Daun Keo, Cambodia | |
| Kampong Cham Hospital | Not yet recruiting |
| Kampong Cham, Cambodia | |
| Neak Loeung Hospital | Not yet recruiting |
| Neak Loeung, Cambodia | |
| Khmero-Soviet Friendship Hospital | Not yet recruiting |
| Phnom Penh, Cambodia | |
| Calmette Hospital | Not yet recruiting |
| Phnom Penh, Cambodia | |
| Preah Kossamak Hospital | Not yet recruiting |
| Phnom Penh, Cambodia | |
| Hope Center | Not yet recruiting |
| Phnom Penh, Cambodia | |
| Social Health Clinic | Recruiting |
| Phnom Penh, Cambodia | |
| Preahketomealea Hospital | Not yet recruiting |
| Phnom Penh, Cambodia | |
| Siem Reap Hospital | Not yet recruiting |
| Siem Reap, Cambodia | |
| Sihanouk Ville Hospital | Not yet recruiting |
| Sihanouk Ville, Cambodia | |
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
| Study Chair: | Vonthanak Saphonn, MD | Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS) |
| Study Chair: | Eric Nerrienet, MD | Institut Pasteur, Paris, France |
| Study Chair: | Bruno Spire, MD | Observatoire Régional de la Santé, Marseille, France |
More Information
No publications provided
| Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
| ClinicalTrials.gov Identifier: | NCT01801618 History of Changes |
| Other Study ID Numbers: | ANRS12276 2PICAM |
| Study First Received: | February 22, 2013 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Cambodia: Ministry of Health |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
HIV PI based 2nd line ARV treatment Virological failure |
Drug resistance Cambodia Adherence |
ClinicalTrials.gov processed this record on May 22, 2013