Best way to manage dolutegravir resistance in people with HIV

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 randomized Phase 3 trial enrolls people aged 3 years and older from the Ndovu cohort who have HIV-1 RNA ≥200 copies/mL and at least one major dolutegravir-associated resistance mutation. Participants are randomized to either remain on their dolutegravir-based regimen or switch to darunavir plus ritonavir, with regular follow-up to compare viral suppression and safety outcomes. The trial is conducted at multiple Kenyan hospital sites and uses baseline drug resistance testing to define eligibility. Findings will clarify whether continuation of dolutegravir is acceptable or whether switching to a protease inhibitor improves virologic control in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Enrolled in the Ndovu cohort study
* Able and willing to understand and comply with the protocol requirements, instructions and restrictions
* Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if \< 18 years)
* Age ≥ 3 years
* Most recent HIV-1 RNA ≥ 200 copies/mL
* At least one major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K/A/T, 140S/A/C, 148H/R/K, 155H or 263K)

Exclusion Criteria:

* Pregnant or breastfeeding
* Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs
* WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening
* Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons
* Investigator opinion that the potential participant should not switch to DRV/r for clinical reasons

Where it's running

• Jaramogi Oginga Odinga Teaching and Referral Hospital
  Kisumu, Kenya Recruiting
• Kenyatta National Hospital
  Nairobi, Kenya Recruiting
• Bomu Hospital
  Mombasa, Kenya Not yet recruiting
• Butha-Buthe District Hospital
  Butha-Buthe, Lesotho Not yet recruiting
• Mokhotlong District Hospital
  Mokhotlong, Lesotho Not yet recruiting
• CS Ponta Gea
  Beira, Sofala, Mozambique Not yet recruiting

Study contacts

• Principal investigator: Loice A Ombajo, MMed, MSc — University of Nairobi
• Study coordinator: Joseph Nkuranga, MBChB, MSc
• Email: dnkuranga@uonbi.ac.ke
• Phone: +254737223988

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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.