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HIV patients test weekly shots to replace daily pills

NCT ID NCT05271370

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether HIV patients who already had the virus under control could switch to weekly injections of leronlimab (PRO 140) instead of their usual daily pills. The goal was to see if the drug alone could keep the virus suppressed safely over a longer period. The trial was terminated early, so the full results are not available.

What this could mean

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

Active substance
leronlimab (PRO 140)
What this could lead to
If successful, this could show that leronlimab alone can keep HIV under control long-term, potentially reducing the need for daily oral medications.
What could go wrong
The study was terminated early with only 56 participants, so results are limited. It is unclear if leronlimab monotherapy can reliably prevent viral rebound, and there may be side effects like injection reactions.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

56 people

The number who actually took part.

Started

Aug 2017

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Subjects who have completed 48 weeks of treatment in PRO140\_CD03 study. 2. Last known Plasma HIV-1 RNA \< 50 copies/mL within PRO140\_CD03 study. 3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives \[male condom, female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug. 4. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent. Exclusion Criteria: 1. Not currently enrolled in PRO140\_CD03 study. 2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma). 3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study. 4. Subjects weighing \< 35kg. 5. History of anaphylaxis to any oral or parenteral drugs. 6. History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin). Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant therapy dose with documented stable INRs can be enrolled as per discretion of the Investigator. 7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Quest Clinical Research

    San Francisco, California, 94115, United States

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