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New hope for HIV patients with organ transplants: simpler drug combo under study

NCT ID NCT03360682

Disease control Sponsor: Fundacion Clinic per a la Recerca Biomédica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This pilot study tested a combination of HIV drugs (dolutegravir plus two NRTIs) in 19 HIV-positive people who had received a solid organ transplant (heart, liver, or kidney). The goal was to see how the HIV drugs interact with transplant medications and whether the regimen is safe and effective. Participants took the drugs for 48 weeks, and researchers monitored drug levels, viral load, and immune cell counts.

What this could mean

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

Active substance
dolutegravir, lamivudine, abacavir, tenofovir disoproxil, emtricitabine
What this could lead to
If successful, this could show that a simpler HIV drug regimen is safe and effective for people who have had an organ transplant.
What could go wrong
This is a very small pilot study with only 19 participants, so results may not apply to everyone. Drug interactions with transplant medications could still cause problems.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

19 people

The number who actually took part.

Started

Apr 2018

Finished

May 2020

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

18 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: 1. HIV patients \>18 years old who provide signed and dated informed consent; 2. Males and females; 3. SOT recipients (heart, liver or kidney); 4. On stable antiretroviral therapy (ART) for ≥6 months preceding the screening visit; 5. Plasma HIV RNA \<50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load \>50 between determinations); 6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing Exclusion Criteria: 1. HIV patients who have stopped ART due to virological failure; 2. HIV patients who require treatment with DTG contraindicated medications; 3. History or presence of an allergy or intolerance to the study drug; 4. Active opportunistic infection; 5. Neoplasms requiring chemotherapy. 6. Pregnancy or breast feeding or planned pregnancy during the study period 7. Any other contraindication to study drugs.

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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 Solid organ transplant

Contacts and locations

Locations

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.