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

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

This study is testing if switching to a new two-pill HIV treatment can keep people with HIV healthy and undetectable after they’ve been on a stable three-pill regimen.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chelsea and Westminster NHS Foundation Trust (other)
• Drugs / interventions: cART
• Locations: 3 sites (London and 2 other locations)
• Trial ID: NCT04892654 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are HIV-1 infected individuals aged 18 and older who have been on stable and suppressive triple cART for at least six months.

Not a fit: Patients with a history of virological failure on certain antiretroviral classes or those with specific medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and less toxic treatment option for patients living with HIV.

How similar studies have performed: Other studies have shown promise in using dual therapy approaches for HIV treatment, suggesting potential for success in this novel application.

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

Where this trial is running

London and 2 other locations

• 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

Conditions: HIV-1-infection, HIV, Doravirine, Dolutegravir, cART