Investigating the Optimal Management of Dolutegravir Resistance

NCT06762054 | Recruiting

• 1 other identifier: Ndovu Cohort Study
• Study Type: observational
• Target: 6,600
• Locations: 4 countries
• Sites: 9

Brief Summary

The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen. The study will also assess the emergence of DTG-associated drug-resistant mutations and their impact on viral suppression.

Conditions

HIV-1-infection

Keywords

HIV; Dolutegravir; Treatment failure; Drug resistant mutations; Dolutegravir resistance; Re-suppression

Outcome Measures

Primary Outcomes (1)

• Viral suppression rate

  Viral suppression rate following enhanced adherence counseling

  12 months

Secondary Outcomes (10)

• Time to viral suppression

  12 months

• Viral suppression by age strata

  12 months

• Viral suppression by viral load strata

  12 months

• Viral suppression by sex at birth

  12 months

• Viral suppression by nucleoside/nucleotide reverse transcriptase inhibitor (NRTI)

  12 months

Interventions

Continue DTG-based antiretroviral therapy DRUG

Participants will continue on DTG-based ART after enrollment for up to 12 months

Enhanced adherence counselling BEHAVIORAL

Participants with VL ≥200 copies/mL will undergo enhanced adherence counselling

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be recruited without advertisement from the pool of patients receiving routine outpatient HIV care at the study sites and at surrounding HIV clinics in 8 central study sites in Kenya, 1 central study site in Tanzania (enrolling from surrounding care and treatment centres in Dar es Salaam), 6 study sites in Mozambique, and 5 study sites in Lesotho. The target sample size for this study is 6,600 participants. Participants who develop DTG-associated DRMs during cohort follow-up will be assessed for eligibility into a clinical trial assessing the optimal management of people who develop drug resistance to DTG-based ART (Ndovu RCT).

You may qualify if:

• Able and willing to provide informed consent (assent as appropriate and legal guardian consent if \< 18 years)
• Age ≥ 1 years
• Documented HIV-1 infection as confirmed by national HIV testing standards at the respective study sites
• On a DTG-based ART regimen for at least six months
• Most recent HIV-1 RNA ≥ 1,000 copies/mL within 3 months prior to enrolment, taken after at least 6 months on current ART regimen

You may not qualify if:

• Has switched ART regimen for confirmed or suspected HIV treatment failure while on a PI- or INSTI-based regimen
• Any reason which, in the investigator's opinion, will significantly prevent the collection of viral load levels such as relocation to another area outside of the trial sites or imminent death
• Concomitant NNRTI or PI while on DTG

Sponsors & Collaborators

• University of Nairobi: lead
• Instituto Nacional de Saúde, Mozambique: collaborator
• Muhimbili University of Health and Allied Sciences: collaborator
• SolidarMed: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (9)

Jaramogi Oginga Odinga Teaching and Referral Hospital

Kisumu, Kenya

RECRUITING

Bomu Hospital

Mombasa, Kenya

NOT YET RECRUITING

Kenyatta National Hospital

Nairobi, 00100, Kenya

RECRUITING

Butha-Buthe District Hospital

Butha-Buthe, Lesotho

RECRUITING

Mokhotlong District Hospital

Mokhotlong, Lesotho

RECRUITING

CS Ponta Gea

Beira, Sofala, Mozambique

NOT YET RECRUITING

CS Machava II

Maputo, Mozambique

NOT YET RECRUITING

CS Ndlavela

Maputo, Mozambique

NOT YET RECRUITING

MUHAS Clinical Trial Unit

Dar es Salaam, Tanzania

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples stored at baseline and at all timepoints where a viral load test is conducted for possible HIV drug resistance testing (DRT)

Study Officials

• Loice A Ombajo, MMed, MSc

  University of Nairobi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Nkuranga, MBChB, MSc

CONTACT

+254737223988; dnkuranga@uonbi.ac.ke

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 7, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the final manuscript and for a period of 36 months
• Access Criteria: Access to IPD will be subject to the University of Nairobi data sharing requirements. Written requests should be submitted to the Principal Investigator providing a brief description of the individual or group making the request and detailing the reason for the same. Prior to sharing the data, the requestor will be required to sign a data access and sharing agreement.

Locations

LE (2); KE (3); MO (3); TA (1)