Evaluation of Switching From Current cART to Triumeq With Adherence Support Will Enhance HIV Control in Vulnerable Populations (TRIIADD)
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|ClinicalTrials.gov Identifier: NCT02354053|
Recruitment Status : Recruiting
First Posted : February 3, 2015
Last Update Posted : April 27, 2018
Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored therapy for HIV patients. While modern regimens have improved the rates of virologic suppression overall and reduced adverse effects of antiretroviral treatment, an important sub-group of HIV infected persons is unable to maintain adherence to their treatment regimens, fail to achieve long term virologic control and remain at risk for HIV related disease progression and transmission of HIV infection.
Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Switch to Triumeq Behavioral: Adherence support + current ART||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV, Multicentre Randomized Prospective Open Label Study to Evaluate Whether Switching From Current cART to Triumeq in Addition to Adherence Support Will Enhance Virologic Control and Adherence in Vulnerable Populations Relative to Adherence Support Alone|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||January 2019|
Active Comparator: Current ART
Current ART + adherence support
Behavioral: Adherence support + current ART
Triumeq + adherence support
Drug: Switch to Triumeq
Behavioral: Adherence support + current ART
- Evaluation of efficacy of the Switch from ART to Triumeq with adherence support as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization. [ Time Frame: 24 weeks ]To determine if switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART.
- Improve of average adherence [ Time Frame: 24 weeks ]
To determine if switching from current cART to a Triumeq based regimen will improve the average adherence of patients compared to maintaining current cART, measured at 24 weeks post randomization. We will use a set of questionnaires:
- HIV treatment knowledge questionnaire: this questionnaire will help to identify any patients that may need psycho-education regarding HIV treatment (patients who failed to answer to any knowledge item)
- Experience of Close Relationships (ECR-short)
- Patient Health Questionnaire (PHQ9).
- Alcohol: Audit C:
- Drug abuse Drug Use Disorders Identification Test (DUDIT)27.
- Quality of life using the EuroQoL EQ-5D tool
- HIV Cost and Services Utilization Study questionnaire.
- Maintaining Adherence over the time [ Time Frame: 72 weeks ]To determine if adherence is maintained over the long term (up to 72 weeks) in subjects receiving Triumeq
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354053
|Contact: Marina Klein, MD||514-934-1934 ext firstname.lastname@example.org|
|Contact: Natacha Cotta-Grand, PhD||514-934-1934 ext email@example.com|
|Chronic Viral Illness Service||Recruiting|
|Montreal, Quebec, Canada, H4A 3J1|
|Contact: Natacha Cotta-Grand, PhD firstname.lastname@example.org|
|Principal Investigator: Marina Klein, MD|
|Sub-Investigator: Bertrand Lebouché, MD|
|Sub-Investigator: Joe Cox, MD|
|Sub-Investigator: Jean-Pierre Routy, MD|
|Sub-Investigator: Cecilia Costiniuk, MD|
|Sub-Investigator: Alexandra de Pokomandy, MD|
|Principal Investigator:||Marina Klein, MD||Chronic Viral Illness Service|