HIV drug extension study halted early: what happened?
NCT ID NCT02990858
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether weekly injections of PRO 140, taken with standard HIV medications, could keep the virus under control over the long term. It enrolled 43 people who had already completed an earlier PRO 140 study and had undetectable virus levels. The study was terminated early, so final results are limited.
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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
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43 people
The number who actually took part.
- Started
-
Nov 2016
- Finished
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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: Potential subjects are required to meet all of the following criteria for enrollment into the study. 1. Subjects who have completed 24 weeks of treatment in PRO 140\_CD 02 or CD02\_OpenLabel study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression. 2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140\_CD02 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 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 subcutaneous (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: Potential subjects meeting any of the following criteria will be excluded from enrollment. 1. Not currently enrolled in PRO 140\_CD 02 or CD02\_OpenLabel 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. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures
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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.
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