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Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

NCT06747507 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2025-09-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dolutegravir Pill

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

DRUG

Darunavir+Ritonavir

Dose will be based on weight

Sponsors & Collaborators

  • Instituto Nacional de Saúde, Mozambique

    collaborator OTHER_GOV

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • SolidarMed

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • University of Nairobi

    lead OTHER

Principal Investigators

  • Loice A Ombajo, MMed, MSc · University of Nairobi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Kenya
  • Lesotho
  • Mozambique
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06747507 on ClinicalTrials.gov