Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

NCT02859961 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO 140_CD03
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 12

Brief Summary

This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry. Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure

  The proportion of participants experiencing virologic failure was analyzed and reported. Virological failure is defined as two consecutive plasma HIV-1 RNA levels of \>= 200 copies/mL.

  From T1 (first treatment administration) to week 48 (T48).

Secondary Outcomes (13)

• Proportion of Participants Experiencing Virologic Failure While on PRO 140 Monotherapy Regimen

  From T1 (first treatment administration) to week 48 (T48).

• Time to Virologic Failure After Initiating PRO 140 Monotherapy

  From T1 (first treatment administration) to week 48 (T48).

• Proportion of Participants Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure.

  From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).

• Time to Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure

  From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).

• Proportion of Participants With Viral Suppression (HIV-1 RNA < 50 Copies/mL) at Week 48 From the Start of PRO 140 Treatment Phase.

  From T1 (first treatment administration) to week 48 (T48).

Other Outcomes (3)

• Tolerability of Repeated Subcutaneous Administration of PRO 140

  From T1 (first treatment administration) to week 48 (T48)

• Frequency of Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale

  From T1 (first treatment administration) to week 48 (T48).

• Frequency of Treatment-Emergent Serious Adverse Events

  From T1 (first treatment administration) to week 48 (T48).

Study Arms (6)

Part 1 - 350 mg weekly injections of PRO 140, no VF (Group A)

EXPERIMENTAL

350 mg SC injections of PRO 140 per week, patients who had no Virologic Failure (VF)

Drug: PRO 140 (350 mg)

Part 1 - 525 mg weekly injections of PRO 140, no VF (Group B)

EXPERIMENTAL

525 mg SC injections of PRO 140 per week, patients who had no Virologic Failure (VF)

Drug: PRO 140 (525 mg)

Part 1 - 700 mg weekly injections of PRO 140 (Group C)

EXPERIMENTAL

700 mg SC injections of PRO 140 per week

Drug: PRO 140 (700 mg)

Part 2 - Rescue Arm for Group A, 525 mg PRO 140

EXPERIMENTAL

525 mg SC injections of PRO 140 per week after experiencing virologic failure on 350 mg dose

Drug: PRO 140 (525 mg)

Part 2 - Rescue Arm for Group B, 700 mg PRO 140

EXPERIMENTAL

700 mg SC injections of PRO 140 per week after experiencing virologic failure on 525 mg dose

Drug: PRO 140 (700 mg)

Part 2 - Rescue Arm for Group A, 700 mg PRO 140

EXPERIMENTAL

700 mg SC injections of PRO 140 per week after experiencing virologic failure on 350 mg dose

Drug: PRO 140 (700 mg)

Interventions

PRO 140 (350 mg) DRUG

PRO 140 350 mg (175 mg/mL) SC injection per week

Also known as: Leronlimab

Part 1 - 350 mg weekly injections of PRO 140, no VF (Group A)

PRO 140 (525 mg) DRUG

PRO 140 525 mg (175 mg/mL) SC injection per week

Also known as: Leronlimab

Part 1 - 525 mg weekly injections of PRO 140, no VF (Group B); Part 2 - Rescue Arm for Group A, 525 mg PRO 140

PRO 140 (700 mg) DRUG

PRO 140 700 mg (175 mg/mL) SC injection per week

Also known as: Leronlimab

Part 1 - 700 mg weekly injections of PRO 140 (Group C); Part 2 - Rescue Arm for Group A, 700 mg PRO 140; Part 2 - Rescue Arm for Group B, 700 mg PRO 140

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age ≥18 years
• Receiving combination antiretroviral therapy for last 24 weeks
• No change in ART within last 4 weeks prior to Screening Visit
• Subject has two or more potential alternative approved ART drug options to consider.
• Exclusive CCR5-tropic virus at Screening Visit
• Plasma HIV-1 RNA \< 50 copies/mL at Screening Visit
• CD4 cell count of \> 200 cells/mm3 since initiation of anti-retroviral therapy
• CD4 cell count of \> 350 cells/mm3 in preceding 24 weeks and at 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

You may not qualify if:

• CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay
• Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
• Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
• Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
• 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 or during the study.
• Subjects who have failed on a maraviroc containing regimen.
• Subjects weighing \< 35kg
• History of anaphylaxis to any 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

Sponsors & Collaborators

• CytoDyn, Inc.: lead

Study Sites (12)

CD03 Investigational site

La Mesa, California, 91942, United States

Location

CD03 Investigational site

Palm Springs, California, 92262, United States

Location

CD03 Investigational site

San Francisco, California, 94115, United States

Location

CD03 Investigational site

New Haven, Connecticut, 06510, United States

Location

CD03 Investigational site

Norwalk, Connecticut, 06850, United States

Location

CD03 Investigational site

Ft. Pierce, Florida, 34982, United States

Location

CD03 Investigational site

Orlando, Florida, 32803, United States

Location

CD03 Investigational site

West Palm Beach, Florida, 33401, United States

Location

CD03 Investigational site

Wichita, Kansas, 67214, United States

Location

CD03 Investigational site

Las Vegas, Nevada, 89109, United States

Location

CD03 Investigational site

New York, New York, 10011, United States

Location

CD03 Investigational site

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

leronlimab

Limitations and Caveats

The outcome and safety data came from a report from the contract research organization that oversaw the study.

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: CytoDyn

jmeidling@cytodyn.com

(360) 980-8524

Study Officials

• Jacob Lalezari, MD

  CytoDyn, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: August 9, 2016
• Study Start: December 7, 2016
• Primary Completion: September 16, 2020
• Study Completion: December 7, 2020
• Last Updated: March 4, 2026
• Results First Posted: March 4, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)