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Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (DORDOL)

Who is this study for? People living with HIV with an undetectable viral load
What treatments are being studied? Doravirine+Dolutegravir
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of cART can lead to side-effects through exposure to drug-related toxicity. For this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV. The purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• HIV-1 infected, 18 years or older

• On stable \& suppressive triple cART for at least 6 months

• No evidence of resistance to DOR or DTG

• No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators

• Women who are pre-menopausal and sexually active should be on one of the following methods of contraception:

‣ Implant

⁃ Depot injection

⁃ Intra-uterine device or system

⁃ Oral hormonal contraception

Locations
Other Locations
United Kingdom
Chelsea & Westminster Hospital NHS Foundation Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
Mortimer Market Centre
RECRUITING
London
Contact Information
Primary
Research Regulatory Compliance Manager
chelwest.research@nhs.net
020 3315 6825
Time Frame
Start Date: 2022-08-17
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 150
Treatments
Experimental: Immediate Switch
Two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 96 weeks.
Other: Delayed Switch
Participants will continue their current triple cART regimen for 48 weeks. Patients will then be switched to two-pill regimen, doravirine (100 mg) + dolutegravir (50 mg) tablets taken orally once daily for 48 weeks.
Related Therapeutic Areas
Sponsors
Leads: Chelsea and Westminster NHS Foundation Trust

This content was sourced from clinicaltrials.gov