Health Trials

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

ConditionHIV-1-infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3+
SponsorUniversity of Nairobi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dolutegravir Pill

    Drug

    Dose will be based on weight; brand names will be as supplied through the respective national programs

  • Darunavir+Ritonavir

    Drug

    Dose will be based on weight

Treatment groups

392 Participants
are divided into 2 treatment groups
Group A: Continue on DTG-based TherapyExperimental treatment 1 intervention
Group B: Switch to PI-based TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with HIV-1 RNA of <200 copies/mL at 6 months

The comparative efficacy of switching to a DRV/r-based regimen after confirmed virologic failure and of remaining on DTG-based ART in achieving viral suppression of \<200 copies/mL at 6 months from randomization among participants with ≥1 major DTG-associated DRM

Time frame
6 months

Secondary outcomes

1

Proportion of participants with HIV-1 RNA of <200 copies/mL at 12 months

Viral suppression to HIV-RNA of \<200 copies/mL at 12 months from randomization

Time frame
12 months
2

Superiority of switch to DRV/r

Evaluate if switching to DRV/r-based ART after virologic failure is superior to remaining on DTG-based ART in achieving viral suppression to \<200 copies/mL at 6 months from randomization

Time frame
6 months
3

Viral suppression with cut-off of 50 copies/mL

Evaluate the difference in viral suppression using HIV-RNA cut-off of \<50 copies/mL at 6 and 12 months from randomization

Time frame
6 and 12 months
4

Viral suppression with cut-off of 1,000 copies/mL

Evaluate the difference in viral suppression using HIV-RNA cut-off of \<1,000 copies/mL at 6 and 12 months from randomization

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

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University of Nairobi

Lead sponsor

Instituto Nacional de Saúde, Mozambique

Collaborator

Muhimbili University of Health and Allied Sciences

Collaborator

SolidarMed

Collaborator

London School of Hygiene and Tropical Medicine

Collaborator

Source ClinicalTrials.gov
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