Treatment and Care
Co-infections and Related Conditions (CRC)
About The Study
The aim of this study is to determine whether a new single-tablet treatment (Triumeq) combined with adherence support will be more effective than existing combination medications (cART) in achieving viral suppression. This research study addresses the challenge some people living with HIV face in controlling their viral load, especially people from higher-risk populations. The study will evaluate if single-tablet regimens are better than multi-tablet regimens for people who show difficulty in medication adherence.
About The Disease
Modern HIV therapy offers many choices and allows for customized treatments for individual patients. For many people, these new therapies have led to undetectable HIV levels and low risks of transmission and illness. However, while new HIV treatments are better at controlling the virus and have fewer side effects, many people are unable to take their medications in the prescribed way and thus have been unable to achieve undetectable viral loads. As many as 30% of people living with HIV infection do not consistently have undetectable HIV levels due to very rigid regimens of HIV therapy that are often difficult to follow.
An ideal treatment should be simple, well tolerated, and combine well with treatments for other illnesses. The treatment should also easily fit into daily life where other considerations such as work, finances, and food insecurity can make it difficult to take medications regularly. Once-a-day HIV therapies and single tablet regimens (STR) are likely to increase adherence and therefore increase the chance of suppressing the virus.
Study Approach
This will be the first randomized, controlled trial that will directly evaluate if switching to an STR (Triumeq) will improve adherence rates and HIV control.
Researchers are looking to recruit 100 participants from 14 CTN-affiliate sites across Canada. The study will continue for seventy-two weeks (1.5 years) and will require up to 11 clinical visits. Participants will be randomly assigned to one of two groups. The first group will immediately switch to Triumeq and receive adherence support counselling. The second group will continue to take their current medication and receive adherence support for twenty-four weeks after which they will be given the choice to switch. Patients will be contacted by a nurse during week 76 to collect information on any side effects that may occur after week 72.
Eligibility Requirements
Required
- HIV-1 infected adults 18 years of age or older
- Prescribed cART that may include any DHHS regimens except dolutegravir
- Evidence of non-adherence to current cART regimen
- Documentation that the person is negative for HLA-B*5701 allele
- Women who are suspected or planning to become pregnant or breastfeeding must have a negative pregnancy test at screening and Day 1 and agree to use approved methods of birth control while on study
- Heterosexual men should use at least one barrier method of contraception (e.g. condom)
For more information on inclusion and exclusion criteria, please refer to clinicaltrials.gov.
Not Allowed
- Women who are pregnant or breastfeeding
- Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease except cutaneous Kaposi’s sarcoma not requiring systemic therapy
- Subjects with moderate to severe liver impairment (Class B or C) as determined by Child-Pugh classification
- Anticipated need for Hepatitis C virus (HCV) therapy during the study
- Chronic hepatitis B infection
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class
- Concomitant medications, dofetilide and immunosuppressants
Additional Information
If you would like more information on this clinical study, please refer to a participating site.
Principal Investigators
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Participating Sites
Royal Victoria Hospital/McGill University Health Centre(MUHC) - Chronic Viral Illness Service
Montréal, QC
Dr. Marina Klein
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