Actively Recruiting
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
Led by Chelsea and Westminster NHS Foundation Trust · Updated on 2023-10-25
150
Participants Needed
3
Research Sites
275 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV-1 infected, aged 18 years or older
- On stable and suppressive triple cART regimen for at least 6 months
- No evidence of resistance to doravirine or dolutegravir
- No laboratory abnormalities, medical or psychiatric conditions, or alcohol/drug use that prevent participation
- Premenopausal women who are sexually active must use one of the following contraception methods: implant, depot injection, intra-uterine device or system, or oral hormonal contraception
You will not qualify if you...
- History of virological failure on an NNRTI without a resistance test confirming no resistance to doravirine
- History of virological failure on an INSTI without a resistance test confirming no resistance to dolutegravir
- Use of medications that interact negatively with doravirine or dolutegravir
- Hemoglobin less than 9 g/dL
- Platelet count less than 80,000/mm3
- Creatinine clearance below 30 mL/min
- AST or ALT levels five times above normal
- Acute Hepatitis A infection
- Current treatment with direct-acting antivirals for Hepatitis C
- Known acute or chronic viral hepatitis B or C (except certain antibody positive cases without active infection)
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Mortimer Market Centre
London, United Kingdom, NW1 0PE
Actively Recruiting
2
Chelsea & Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
Actively Recruiting
3
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
R
Research Regulatory Compliance Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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