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HIV drug resistance showdown: stay or switch?

NCT ID NCT06747507

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This trial looks at what to do when the HIV virus becomes resistant to the drug dolutegravir. It compares staying on dolutegravir versus switching to another drug combination (darunavir/ritonavir) to see which better lowers the virus level. About 392 people with HIV and specific resistance mutations will take part.

What this could mean

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

Active substance
dolutegravir pill or darunavir+ritonavir pill
What this could lead to
If it works, this could show the best way to manage HIV when the virus becomes resistant to dolutegravir, helping more people achieve viral suppression.
What could go wrong
This is a Phase 3 trial, but it only includes people with specific resistance mutations, so results may not apply to everyone. There is also a risk that neither strategy works well.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 392 people

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

Started

Sep 2025

Expected to finish

Jul 2027

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.

Ages

3 years 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: * 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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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

    NOT_YET_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

    NOT_YET_RECRUITING

    Mokhotlong, Lesotho

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