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|
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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 as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization.
In vulnerable populations non-adherent to their current cART:
(i) 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.
(ii) To determine if adherence is maintained over the long term (up to 72 weeks) in subjects receiving Triumeq (iii) To evaluate the effect of switching to Triumeq on control of HIV infection (as measured by HIV viral load and CD4 cell counts) up to 72 weeks (iv) To determine the safety of using Triumeq with respect to risk for the emergence of HIV drug resistance.
(vi) To assess the safety and tolerability (including hepatic function and metabolic profiles) of switching from current cART regimen to Triumeq up to 72 weeks.
(vi) To evaluate if switching to Triumeq will be cost effective from a societal prospective
We will recruit from 14 CTN-affiliated sites across Canada.
All patients recruited into the trial will be adults aged over 18 years old with documented HIV infection (ELISA with western blot confirmation) and with negative HLA-B5701 testing. Prescribed ART may include any DHHS recommended or alternative regimens, which the treating physician considers, is appropriate for their patient (except dolutegravir) for at least 6 months. Subjects will have evidence of non-adherence to current ART regimen defined as:
- HIV RNA ≥400 copies/ml at least once in last 12 months
- Absence of evidence of resistance to any component of the current regimen or Triumeq
- Viremia not explained by normal viral decay after initiating ART We anticipate that many of recruited subjects will comprise people who inject drugs, Aborginal persons and persons from ethnocultural communities however recruitment will not be limited to these groups as others may be enrolled provided they meet the inclusion criteria.
A randomized, prospective, open-label study. Patients will be randomized 1:1 to switch to Triumeq vs. to remain on current cART. Both groups will receive adherence support. Those randomized to maintain current cART will be permitted to switch to Triumeq after 24 weeks.
N = 100 100 patients (50/arm) will provide 80% power to detect a 25% difference in virologic suppression rates between the two arms at 24 weeks. While this difference is large, for the population we are targeting we consider that an improvement in virologic suppression rates of at least this amount would be required to be clinically meaningful.
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354053
|Contact: Marina Klein, MD||514-934-1934 ext email@example.com|
|Contact: Natacha Cotta-Grand, PhD||514-934-1934 ext firstname.lastname@example.org|
|Chronic Viral Illness Service||Recruiting|
|Montreal, Quebec, Canada, H4A 3J1|
|Contact: Natacha Cotta-Grand, PhD email@example.com|
|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|