A Phase 2/3 interventional study of PRO 140 in Human Immunodeficiency Virus (HIV), sponsored by CytoDyn, Inc.. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by CytoDyn, Inc. · Phase 2/3, Interventional, and Treatment
PRO 140_CD02 Extension study seeks to evaluate the long-term efficacy, safety and tolerability of PRO 140 weekly injection in combination with Optimized Background Therapy (OBT) in patients infected with Human Immunodeficiency virus (HIV-1).
This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with C-C Chemokine Receptor Type 5 (CCR5)-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 or CD02_OpenLabel study.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 43 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →CytoDyn, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.
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.
Exclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment.
The treatment extension phase consists of weekly treatment injection of PRO 140 in addition to Optimized Background Therapy.
Drug: PRO 140
PRO 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5). Participants received 350 or 700 mg weekly injections of PRO 140.
Also known as: Leronlimab
Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period
The change from baseline in HIV-1 RNA levels (log 10 copies/mL) was summarized at least once every four weeks during the treatment extension phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.
Time frame: From TE1 (first treatment administration) to once every four weeks until last treatment visit (up to 56 months).
Mean Change in CD4 Cell Count at the Conclusion of Treatment Period
The change from baseline in CD4 cell count was summarized for each visit during the treatment phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.
Time frame: From first treatment administration to each weekly visit until the last treatment visit (up to 56 months)
Proportion of Participants Experiencing Emergence of Dual/Mixed (D/M)- and CXCR4-tropic Virus in Patients Who Had Exclusive CCR5-tropic Virus at Study Entry.
All patients have exclusive C-C chemokine receptor type 5 (CCR5)-tropic virus at study entry. The proportion of patients with any tropism result of dual/mixed was summarized.
Time frame: From TE1 (first treatment administration) to last treatment visit, up to 56 months.
Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Investigator Evaluation of Injection Site Reactions (ISR)
At each visit during the treatment extension phase, an injection site reaction assessment was completed for the current and previous injection sites. To assess severity, subcutaneous (SC) injection related events were recorded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Grade 1 indicates a mild event Grade 2 indicates a moderate event Grade 3 indicates a severe event Grade 4 indicates a potentially life-threatening event Participants who had no symptoms of injection site reactions, "0" was assigned.
Time frame: From TE1 (first treatment administration) weekly until last treatment visit (up to 56 months).
Number of Participants With Treatment-related Adverse Events Resulting in Study Drug Discontinuation
Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).
Time frame: From TE1 (first treatment administration) to last treatment visit, up to 56 months.
Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale
The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).
Time frame: From TE1 (first treatment administration) to last treatment visit, up to 56 months.
Number of Participants With at Least One Treatment-related Serious Adverse Event.
Treatment-related (as defined by the investigator) serious adverse events are defined as serious events with an onset on or after the first treatment. A serious adverse event is defined as any adverse event that: * Results in death * Is life threatening (the subject is at immediate risk of dying from the AE) * Requires subject hospitalization or prolongs existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: From TE1 (first treatment administration) to last treatment visit, up to 56 months.
This trial was conducted in 43 participants in the United States.
| Milestone | PRO 140 |
|---|---|
| Started | 43 |
| Completed | 23 |
| Not completed | 20 |
The change from baseline in HIV-1 RNA levels (log 10 copies/mL) was summarized at least once every four weeks during the treatment extension phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.
| log10 copies/mL | PRO 140 |
|---|---|
| Mean Change in Viral Load (HIV-1 RNA Levels) at the Conclusion of Treatment Period | 0.13 ± 1.11 |
The change from baseline in CD4 cell count was summarized for each visit during the treatment phase. The time-weighted mean of change of the post baseline values was calculated. The time-weighted mean was adjusted AUC (area under the curve) by time.
| cells/uL | PRO 140 |
|---|---|
| Mean Change in CD4 Cell Count at the Conclusion of Treatment Period | 46 ± 122 |
All patients have exclusive C-C chemokine receptor type 5 (CCR5)-tropic virus at study entry. The proportion of patients with any tropism result of dual/mixed was summarized.
| proportion of participants | PRO 140 |
|---|---|
| Proportion of Participants Experiencing Emergence of Dual/Mixed (D/M)- and CXCR4-tropic Virus in Patients Who Had Exclusive CCR5-tropic Virus at Study Entry. | 0.093 |
At each visit during the treatment extension phase, an injection site reaction assessment was completed for the current and previous injection sites. To assess severity, subcutaneous (SC) injection related events were recorded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Grade 1 indicates a mild event Grade 2 indicates a moderate event Grade 3 indicates a severe event Grade 4 indicates a potentially life-threatening event Participants who had no symptoms of injection site reactions, "0" was assigned.
| participants | PRO 140 |
|---|---|
| Participants with no ISR symptoms | 20 |
| Participants with Grade 1 ISR | 19 |
| Participants with Grade 2 or higher ISR | 0 |
Treatment-related adverse events are defined as events with an onset on or after the first treatment (TE1).
| participants | PRO 140 |
|---|---|
| Number of Participants With Treatment-related Adverse Events Resulting in Study Drug Discontinuation | 1 |
The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death (Note: This grade is not specifically listed on each page of the grading table).
| participants | PRO 140 |
|---|---|
| Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale | 12 |
Treatment-related (as defined by the investigator) serious adverse events are defined as serious events with an onset on or after the first treatment. A serious adverse event is defined as any adverse event that: * Results in death * Is life threatening (the subject is at immediate risk of dying from the AE) * Requires subject hospitalization or prolongs existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
| Participants | PRO 140 |
|---|---|
| Number of Participants With at Least One Treatment-related Serious Adverse Event. | 15 |
Collected over Adverse events were reported from the time of the first treatment extension visit and continue up until the final study visit, up to 56 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO 140 350 mg | 3/29 (10.3%) | 11/29 (37.9%) | 27/29 (93.1%) |
| PRO 140 700 mg | 1/14 (7.1%) | 4/14 (28.6%) | 13/14 (92.9%) |
| Event | PRO 140 350 mg | PRO 140 700 mg |
|---|---|---|
| Chest painGeneral disorders | 1/29 | 1/14 |
| PyrexiaGeneral disorders | 0/29 | 1/14 |
| DeathGeneral disorders | 0/29 | 1/14 |
| Abscess limbInfections and infestations | 0/29 | 1/14 |
| Head InjuryInjury, poisoning and procedural complications | 0/29 | 1/14 |
| PneumoniaInfections and infestations | 0/29 | 1/14 |
| Acute myocardial infarctionCardiac disorders | 2/29 | 0/14 |
| BronchitisInfections and infestations | 2/29 | 0/14 |
| Coronary artery occlusionCardiac disorders | 1/29 | 0/14 |
| Aplastic anaemiaBlood and lymphatic system disorders | 1/29 | 0/14 |
| Event | PRO 140 350 mg | PRO 140 700 mg |
|---|---|---|
| Urinary tract infectionInfections and infestations | 4/29 | 4/14 |
| NasopharyngitisInfections and infestations | 5/29 | 3/14 |
| DiarrhoeaGastrointestinal disorders | 6/29 | 0/14 |
| Injection site haemorrhageGeneral disorders | 5/29 | 1/14 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/29 | 0/14 |
| Injection site painGeneral disorders | 2/29 | 2/14 |
| EcchymosisSkin and subcutaneous tissue disorders | 3/29 | 2/14 |
| PyrexiaGeneral disorders | 4/29 | 0/14 |
| Chest painGeneral disorders | 4/29 | 1/14 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/29 | 1/14 |
All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population.
| Age, Categorical(Participants) | PRO 140 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 43 |
| >=65 years | 0 |
| Age, Continuous(years) | PRO 140 |
|---|---|
| Mean | 53.07 ± 7.31 |
| Sex: Female, Male(Participants) | PRO 140 |
|---|---|
| Female | 10 |
| Male | 33 |
| Ethnicity (NIH/OMB)(Participants) | PRO 140 |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 34 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PRO 140 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 18 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | PRO 140 |
|---|---|
| United States | 43 |
No study locations are listed for this record.
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Acquired Immunodeficiency Syndrome→
CytoDyn, Inc.