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Could a simpler Two-Drug HIV regimen be just as effective as three?

NCT ID NCT07678268

Disease control Sponsor: Instituto Mexicano del Seguro Social 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests whether a two-drug combination (darunavir/cobicistat plus lamivudine) works as well as a standard three-drug combination (darunavir/cobicistat plus tenofovir alafenamide/emtricitabine) in people with HIV whose virus is already suppressed. The study involves 78 adult men in Mexico who have had undetectable HIV levels for at least 48 weeks. Researchers will compare how well each regimen maintains viral suppression and monitor safety over 24 and 48 weeks.

What this could mean

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

Active substance
Darunavir/Cobicistat plus Lamivudine
What this could lead to
If successful, this could show that a simpler two-drug HIV regimen is as effective as the standard three-drug approach, potentially reducing pill burden and side effects.
What could go wrong
This is a small pilot study with only 78 participants, all men, so results may not apply to everyone. The two-drug regimen might not suppress the virus as well as the three-drug combination.

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

About 78 people

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

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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

Male participants only

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: * Virologically suppressed men living with HIV, transitioning from a DRV/c (800 mg/150 mg) + TDF/FTC (300 mg/200 mg) regimen for at least 48 weeks prior to the study * Viral suppression for 48 weeks prior to the study * Agree to participate in the study by signing a written informed consent form * Age ≥18 years * Glomerular filtration rate (GFR) by CDK-EPI ≥60 mL/min * Beneficiaries of the Mexican Social Security Institute (IMSS) treated at the Infectious Diseases Hospital of the "La Raza" National Medical Center Exclusion Criteria: * Withdrawal of informed consent * Loss of coverage * Failure to attend sample collection within the required timeframe

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Conditions

The condition(s) this trial relates to.

HIV infectious disease lentivirus infection

As listed by the trial registrant

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

Antiretroviral therapy HIV infection Lentivirus infections

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital de Infectología "Dr Daniel Méndez Hernández" National Medical Center "La Raza", Instituto Mexicano del Seguro Social

    RECRUITING

    Mexico City, Mexico City, 02990, Mexico

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