Brief Summary

The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART (antiretroviral therapy) during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jun 2018

Geographic Reach

1 country

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

June 25, 2018

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2020

Completed

5.3 years until next milestone

Results Posted

Study results publicly available

September 16, 2025

Completed

Last Updated

September 16, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

April 2, 2019

Results QC Date

June 5, 2025

Last Update Submit

August 27, 2025

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

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
1-week from baseline to the end of the initial PRO 140 and ART treatment period
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the Initial 1-week Treatment Period
1-week from baseline to the end of the initial PRO 140 and ART treatment period
Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25
25 weeks post-initiation of PRO 140 and existing ART treatment
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25
25 weeks post-initiation of PRO 140 and existing ART treatment
Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL)
25 weeks post-initiation of PRO 140 and existing ART treatment
+2 more secondary outcomes

Study Arms (1)

Leronlimab (PRO 140)

EXPERIMENTAL

Subjects will be on existing ART for one week followed by PRO 140 700 mg weekly subcutaneous (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.

Drug: PRO 140

Interventions

PRO 140DRUG

2 injections of PRO 140 (2 X 2 mL/inj.) Subjects who were previously enrolled and receiving 350 mg dose had the option to move to the 700mg dose for the remainder of the trial.

Also known as: Leronlimab

Leronlimab (PRO 140)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females, age ≥18 years
Exclusive CCR5-tropic virus at Screening Visit as determined by Monogram Biosciences Trofile® Assay
Have a history of at least 3 months on current antiretroviral regimen
Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within three drug classes OR Treatment-experienced HIV-infected patients with documented genotypic or phenotypic resistance to at least one ART drug within two drug classes and have limited treatment option. The options may be limited as a result of drug antiviral class cross-resistance, documented treatment intolerance, documented objective assessments such as renal or hepatic insufficiency (e.g. high creatinine at baseline, limiting treatment options due to potential for toxicity), past adverse reactions such as hypersensitivity reactions or neuropsychiatric issues that could limit use of currently approved drugs.
Be willing to remain on treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
Plasma HIV-1 RNA ≥ 400 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Roche Taqman® Real-Time PCR) and documented detectable viral load (HIV-1 RNA \>50 copies/ml) within the last 3 months prior to Screening Visit
Laboratory values at Screening of:
Absolute neutrophil count (ANC) ≥750/mm3
Hemoglobin (Hb) ≥10.5 gm/dL (male) or ≥ 9.5 gm/dL (female)
Platelets ≥75,000 /mm3
Serum alanine transaminase (SGPT/ALT) \<5 x upper limit of normal (ULN)
Serum aspartate transaminase (SGOT/AST) \<5 x ULN
Bilirubin (total) \<2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
Creatinine ≤1.5 x ULN
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator
+2 more criteria

You may not qualify if:

Documented CXCR4-tropic virus or Dual/Mixed tropic (R5X4) virus as determined by HIV-1 tropism assay
Patients with no viable treatment options ( i.e., no fully active antiretroviral drug available which can be effectively combined to form a viable new OBT)
Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma) Note: Subjects infected by the hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria
Laboratory test values of ≥ grade 3 DAIDS (Division of Acquired Immune Deficiency Syndrome) laboratory abnormality with the exception of the absolute CD4+ count criterion of \<200/mm3
Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
Unexplained fever or clinically significant illness within 1 week prior to the first study dose
Any vaccination within 2 weeks prior to the first study dose
Subjects weighing \< 35kg
History of anaphylaxis to oral or parenteral drugs
History of Bleeding Disorder or patients on anti-coagulant therapy
Participation in an experimental drug trial(s) within 30 days of the Screening Visit
Any known allergy or antibodies to the study drug or excipients
Treatment with any of the following:
Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
Immunosuppressants within 60 days prior to the screening visit
+4 more criteria

Contact the study team to confirm eligibility.