HIV Antibody-Only therapy falls short in Long-Term trial
NCT ID NCT02355184
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a single antibody called PRO 140 could keep HIV under control in 20 adults who had been stable on standard combination therapy. Participants stopped their usual HIV pills and received only PRO 140 infusions. The trial was stopped early, and the main goal was to see how long it took for the virus to come back. This approach aims to simplify HIV treatment but still requires ongoing medication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Nov 2014
- Finished
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Jul 2022
- Lead sponsor
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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
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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 12 weeks of treatment in PRO 140\_CD01 study without experiencing virologic failure. 2. Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug. 3. 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\_CD01 Treatment Substitution Study 2. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition 3. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality. 4. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study 5. Unexplained temperature \>38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose 6. Diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) that in the opinion of the primary care provider and/or site investigator would interfere with the subject's successful completion of the study requirements 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
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CD01-Extension Investigational Site
San Francisco, California, 94115, United States
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Other studies related to the condition(s) this trial covers.
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