Trial Outcomes & Findings for PRO 140 in Treatment-Experienced HIV-1 Subjects (NCT NCT03902522)

Results Overview

The primary endpoint for this study is the proportion of participants with a ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline to the end of the initial 1-week treatment period.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

6 participants

Primary outcome timeframe

1-week from baseline to the end of the initial PRO 140 and ART treatment period

Results posted on

2025-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Leronlimab (PRO 140) Subjects will be on existing ART (antiretrovial therapy) for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PRO 140 in Treatment-Experienced HIV-1 Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leronlimab (PRO 140) n=6 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	52.7 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Years since original HIV Diagnosis	27 Years n=5 Participants

PRIMARY outcome

Timeframe: 1-week from baseline to the end of the initial PRO 140 and ART treatment period

Population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are enrolled and have received at least one dose of PRO 140. Subjects who discontinue from the study prior to their first post-baseline assessment will be included in the ITT population and analyzed as non-responders in the primary safety analysis

The primary endpoint for this study is the proportion of participants with a ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline to the end of the initial 1-week treatment period.

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period	0.80 proportion of participants

SECONDARY outcome

Timeframe: 1-week from baseline to the end of the initial PRO 140 and ART treatment period

Population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are enrolled and have received at least one dose of PRO 140

The secondary endpoint is the proportion of participants with ≥ 1 log10 reduction in HIV-1 RNA viral load from baseline at the end of the initial 1-week treatment period

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Proportion of Participants With ≥ 1 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the Initial 1-week Treatment Period	0.40 proportion of participants

SECONDARY outcome

Timeframe: 1-week from baseline to the end of the initial PRO 140 and ART treatment period

Population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are enrolled and have received at least one dose of PRO 140.

The secondary endpoint is the mean change between baseline and the end of the 1-week of treatment period in HIV-1 RNA levels (log10 copies/mL) (baseline was T1, mean change was calculated between time points T1 and T2). If the mean change is a negative value, this indicates a reduction in viral load.

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the Initial 1-week Treatment Period	-0.69 log10 copies per mL Standard Deviation 0.61

SECONDARY outcome

Timeframe: 25 weeks post-initiation of PRO 140 and existing ART treatment

Population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are enrolled and have received at least one dose of PRO 140

The secondary endpoint is the percentage of participants achieving HIV-1 RNA \< 400 copies/mL at week 25

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25	5 Participants

SECONDARY outcome

Timeframe: 25 weeks post-initiation of PRO 140 and existing ART treatment

Population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are enrolled and have received at least one dose of PRO 140

The secondary outcome measure is the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at week 25

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25	3 Participants

SECONDARY outcome

Timeframe: 25 weeks post-initiation of PRO 140 and existing ART treatment

Population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are enrolled and have received at least one dose of PRO 140

The secondary outcome measure is the mean change in HIV-1 RNA levels (log10 copies/mL) between Baseline (T1) and week 25 (T25). Baseline was T1, mean change was calculated between time points T1 and T25. If the mean change is a negative value, this indicates a reduction in viral load.

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL)	-2.29 log10 copies/mL Standard Deviation 0.63

SECONDARY outcome

Timeframe: 1-week post-initiation of PRO 140 and ART treatment.

Population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are enrolled and have received at least one dose of PRO 140.

The secondary outcome measure is the mean change in CD4 cell count between Baseline and the end of the initial 1-week treatment period (T2). Baseline was T1, mean change was calculated between time points T1 and T2.

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Mean Change From Baseline in CD4 Cell Count at the End of the Initial 1-week Treatment Period	37.4 cells/uL Interval -13.0 to 92.0

SECONDARY outcome

Timeframe: 23 weeks post-initiation of PRO 140 and existing ART treatment

Population: The outcome measure stated change from baseline at week 25 but CD4 cell count data was not collected at week 25. The last week CD4 cell count was collected was week 23. Change from baseline was calculated at week 23.

The secondary outcome measure is the mean change in CD4 cell count between Baseline (T1) and week 23 (T23)

Outcome measures

Outcome measures
Measure	Leronlimab (PRO 140) n=5 Participants Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly SC Inj. + existing ART for the next week. Subsequently, all subjects will enter the 24-week single-arm, open-label treatment period. During this period, all subjects will receive PRO 140 SC injection and Optimized Background Therapy. PRO 140: 2 injections of PRO 140 (2 X 2 mL/inj.)
Mean Change From Baseline in CD4 Cell Count at Week 23	123 cells/uL Interval 3.0 to 254.0

Adverse Events

Leronlimab (PRO 140) + Existing ART

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Leronlimab (PRO 140) + OBT

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Leronlimab (PRO 140) + Existing ART n=6 participants at risk Subjects received existing Anti-Retroviral Therapy (ART) and PRO 140 700 mg SC Injection (T1 - 1 week treatment period).	Leronlimab (PRO 140) + OBT n=6 participants at risk Subjects received PRO 140 weekly SC injection and Optimized Background Therapy (OBT) (T2 - T25 - 24-week treatment period).
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.	16.7% 1/6 • Number of events 1 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.
Cardiac disorders Myocardial infarction	0.00% 0/6 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.	16.7% 1/6 • Number of events 1 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.

Other adverse events

Other adverse events
Measure	Leronlimab (PRO 140) + Existing ART n=6 participants at risk Subjects received existing Anti-Retroviral Therapy (ART) and PRO 140 700 mg SC Injection (T1 - 1 week treatment period).	Leronlimab (PRO 140) + OBT n=6 participants at risk Subjects received PRO 140 weekly SC injection and Optimized Background Therapy (OBT) (T2 - T25 - 24-week treatment period).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/6 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.	16.7% 1/6 • Number of events 1 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.	16.7% 1/6 • Number of events 2 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/6 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.	16.7% 1/6 • Number of events 1 • AEs and SAEs were assessed from T1 visit up to T25 visit (up to 32 weeks). AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the Investigator believes are clinically significant to the research subject and that occurred after initiation of the first study treatment (T1) will be reported as AEs.

Additional Information

Joseph Meidling

CytoDyn

Phone: 13609808524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place