Testing a two-pill HIV treatment for patients switching from triple therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of a dual therapy regimen consisting of doravirine and dolutegravir for individuals living with HIV who are currently on a stable triple combination antiretroviral therapy (cART). Participants will be randomly assigned to either switch to the new two-pill regimen or continue their current treatment for a specified period before switching. The primary outcome will be the percentage of participants maintaining an undetectable viral load after 48 weeks. Additional assessments will include safety, tolerability, and quality of life through questionnaires and laboratory tests.

Why it matters

Who can join: the full rules

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

Where it's running

• Mortimer Market Centre
  London, United Kingdom Recruiting
• Chelsea & Westminster Hospital NHS Foundation Trust
  London, United Kingdom Recruiting
• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Marta Boffito, MD PhD FRCP — Chelsea and Westminster NHS Foundation Trust
• Study coordinator: Research Regulatory Compliance Manager
• Email: chelwest.research@nhs.net
• Phone: 020 3315 6825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.