Status:
RECRUITING
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
Lead Sponsor:
Chelsea and Westminster NHS Foundation Trust
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
A randomised, open label study to assess the efficacy of switching from suppressive triple cART to doravirine + dolutegravir dual cART in people living with HIV (PLWH) with an undetectable viral load ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR
- History of virological failure on an INSTI in absence of a post-failure genotypic resistance test proving absence of resistance to DTG (INSTI mutations that will lead to the need of administering DTG twice-daily are considered as resistance to DTG - and the subject will be considered NOT eligible)
- Concomitant medication contra-indicated with DTG or DOR
- Haemoglobin \<9 g/dL
- Platelets \<80,000/mm3
- Creatinine clearance \<30 mL/min
- AST or ALT ≥5N
- Acute Hepatitis A infection.
- Concomitant DAA for anti-HCV therapy
- Known acute or chronic viral hepatitis B or C.
- Individuals testing positive for HBcAb, but negative HBsAg/HBeAg, may be included on the trial.
- Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial.
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04892654
Start Date
August 17 2022
End Date
November 30 2027
Last Update
October 25 2023
Active Locations (3)
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1
Mortimer Market Centre
London, United Kingdom, NW1 0PE
2
Chelsea & Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
3
Imperial College Healthcare NHS Trust
London, United Kingdom