HIV patients test weekly shots to replace daily pills
NCT ID NCT05271370
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 Hide 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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