NCT04892654 Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
| NCT ID | NCT04892654 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chelsea and Westminster NHS Foundation Trust |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-08-17 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2022-08-17 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Marta Boffito, MD PhD FRCP
PRINCIPAL INVESTIGATOR
Chelsea and Westminster NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04892654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04892654 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT04892654 currently recruiting?
Yes, NCT04892654 is actively recruiting participants. Contact the research team at chelwest.research@nhs.net for enrollment information.
Where is the NCT04892654 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT04892654 clinical trial?
NCT04892654 is sponsored by Chelsea and Westminster NHS Foundation Trust. The principal investigator is Marta Boffito, MD PhD FRCP at Chelsea and Westminster NHS Foundation Trust. The trial plans to enroll 150 participants.
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