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HIV resistance study seeks answers on dolutegravir failure

NCT ID NCT06762054

Knowledge-focused Sponsor: University of Nairobi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows 6,600 people with HIV who have developed resistance to the drug dolutegravir. Researchers want to see if continuing the same medication with extra counseling can still suppress the virus. The goal is to learn more about how resistance develops and how to manage it effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dolutegravir (DTG)
What this could lead to
If successful, this study could provide evidence on whether continuing DTG-based therapy with enhanced counseling is effective for managing resistance, potentially simplifying treatment guidelines.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all populations, and resistance patterns could limit viral suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 6,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bomu Hospital

    NOT_YET_RECRUITING

    Mombasa, Kenya

  • Butha-Buthe District Hospital

    RECRUITING

    Butha-Buthe, Lesotho

  • CS Machava II

    NOT_YET_RECRUITING

    Maputo, Mozambique

  • CS Ndlavela

    NOT_YET_RECRUITING

    Maputo, Mozambique

  • CS Ponta Gea

    NOT_YET_RECRUITING

    Beira, Sofala, Mozambique

  • Jaramogi Oginga Odinga Teaching and Referral Hospital

    RECRUITING

    Kisumu, Kenya

  • Kenyatta National Hospital

    RECRUITING

    Nairobi, 00100, Kenya

  • MUHAS Clinical Trial Unit

    NOT_YET_RECRUITING

    Dar es Salaam, Tanzania

  • Mokhotlong District Hospital

    RECRUITING

    Mokhotlong, Lesotho

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