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Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

RecruitingPhase 3Ages 3 Years - anyAllUniversity of Nairobi
NCT06747507 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.

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📋 Eligibility rules (as published)
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
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What it tests

  • Dolutegravir Pill
  • Darunavir+Ritonavir
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Where

9 sites
Jaramogi Oginga Odinga Teaching and Referral Hospital
Kisumu, Kenya
Bomu Hospital
Mombasa, Kenya
Kenyatta National Hospital
Nairobi, Kenya
Butha-Buthe District Hospital
Butha-Buthe, Lesotho
Mokhotlong District Hospital
Mokhotlong, Lesotho
CS Ponta Gea
Beira, Mozambique
CS Machava II
Maputo, Mozambique
CS Ndlavela
Maputo, Mozambique

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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