Phase 3
N=562
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02859961 ↗Enrolled (actual)
562
Serious AEs
6.0%
Results posted
Mar 2026
Primary outcome: Primary: Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure — 0.23; 0.43; 0.45 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PRO 140 (350 mg) (Drug); PRO 140 (525 mg) (Drug); PRO 140 (700 mg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CytoDyn, Inc.
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure |
0.23; 0.43; 0.45 | — |
| SECONDARY Proportion of Participants Experiencing Virologic Failure While on PRO 140 Monotherapy Regimen |
0.66; 0.42; 0.41 | — |
| SECONDARY Time to Virologic Failure After Initiating PRO 140 Monotherapy |
136.9; 197.7; 200.6 | — |
| SECONDARY Proportion of Participants Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure. |
0.92; 0.79 | — |
| SECONDARY Time to Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure |
78.6; 60.89 | — |
| SECONDARY Proportion of Participants With Viral Suppression (HIV-1 RNA < 50 Copies/mL) at Week 48 From the Start of PRO 140 Treatment Phase. |
0.33; 0.54; 0.41 | — |
| SECONDARY Measurement of Treatment Adherence to the PRO 140 Monotherapy Regimen |
111; 116; 54 | — |
| SECONDARY Total Time That Participants Remain Off Combination ART Regimen, Defined as the Time Between Start of PRO 140 Monotherapy and Restart of Combination ART Regimen |
201.53; 250.48; 273.25 | — |
| SECONDARY Mean Change in CD4 Cell Count, at Each Visit Within the Treatment Phase |
-41.1; -7.4; 7.6 | — |
| SECONDARY Proportion of Participants Within Each Treatment Group Experiencing Emerging Resistance |
0.23; 0.13; 0.13 | — |
| SECONDARY Mean HIV-1 RNA Concentrations in CSF in Central Nervous System (CNS) Sub-study |
1.56; 1.51; 1.90; 1.60; 1; 20.1 | — |
| SECONDARY Mean PRO 140 Concentration in Plasma for Central Nervous System (CNS) Sub-study |
80; 80; 80; 15861.03; 21126.59; 30672.09 | — |
| SECONDARY Mean PRO 140 Concentrations in CSF for Central Nervous System (CNS) Sub-study |
25; 25; 25; 30.87; 40.84; 63.78 | — |
| SECONDARY Mean HIV-1 RNA Concentrations in Genital Secretion in Genitourinary (GU) Sub-study |
1; 1; 1; 1; 258; 38.83 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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 mg/day will be excluded with the following exception:
- Subjects on inhaled, nasal, or topical steroids will not be excluded
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Data sourced from ClinicalTrials.gov (NCT02859961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.