National Evaluation of PI-based 2nd Line Efficacy in Cambodia

NCT01801618 | Completed

• 1 other identifier: ANRS12276 2PICAM
• Study Type: observational
• Target: 15,001,351
• Locations: 1 country
• Sites: 13

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.

Conditions

HIV

Keywords

HIV; PI based 2nd line ARV treatment; Virological failure; Drug resistance; Cambodia; Adherence

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Evaluation of individual risk factors associated with treatment failure

  at inclusion

• Evaluation of structural risk factors associated with treatment failure

  At study initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HIV infection
• age above 18 years
• current PI based 2nd line ARV treatment since at least 6 months
• willing to participate and consent signature

You may not qualify if:

• ongoing PI based 2nd line regimen for less that 6 months at time of study intake

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (13)

Battambang Hospital

Battambang, Cambodia

Location

Chey Chum Neah Hospital

Chey Chum Neah, Cambodia

Location

Daun Keo Hospital

Daun Keo, Cambodia

Location

Kampong Cham Hospital

Kampong Cham, Cambodia

Location

Neak Loeung Hospital

Neak Loeung, Cambodia

Location

Calmette Hospital

Phnom Penh, Cambodia

Location

Hope Center

Phnom Penh, Cambodia

Location

Khmero-Soviet Friendship Hospital

Phnom Penh, Cambodia

Location

Preah Kossamak Hospital

Phnom Penh, Cambodia

Location

Preahketomealea Hospital

Phnom Penh, Cambodia

Location

Social Health Clinic

Phnom Penh, Cambodia

Location

Siem Reap Hospital

Siem Reap, Cambodia

Location

Sihanouk Ville Hospital

Sihanoukville, Cambodia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma HIV RNA and cDNA

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

CA (13)