Phase 3
N=52
Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02483078 ↗Enrolled (actual)
52
Serious AEs
7.7%
Results posted
Nov 2022
Primary outcome: Primary: Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period — .64; .23; .36; .77 Proportion of subjects — p=.0032
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PRO 140 (Drug); Placebo (Drug); Optimized Background Regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CytoDyn, Inc.
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period |
.64; .23; .36; .77 | .0032 sig |
| SECONDARY Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period, Stratified to Each Group: Resistance to ART Drugs Within Two Drug Class With Limited Treatment Option. |
.7273; .2308 | .0377 sig |
| SECONDARY Proportion of Participants With ≥ 0.5 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period, Stratified to Each Group: Resistance to ART Drugs Within Three Drug Classes |
.5714; .2308 | .1201 |
| SECONDARY Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the 1-week Double-blind Treatment Period for All Patients and Within Each Stratum |
0.6; 0.1 | .0013 sig |
| SECONDARY Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25 for All Patients and Within Each Stratum |
37; 3; 12 | — |
| SECONDARY Percentage and Number of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25 for All Patients and Within Each Stratum |
32; 8; 12 | — |
| SECONDARY Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at Week 25 for All Patients and Within Each Stratum |
2.4 | — |
| SECONDARY Mean Change From Baseline in CD4 Cell Count at the End of the 1-week Double-blind Treatment Period for All Patients and Within Each Stratum |
41.1; 25 | .7123 |
| SECONDARY Mean Change From Baseline in CD4 Cell Count at Week 25 for All Patients and Within Each Stratum |
85.9 | — |
| SECONDARY Proportion of Participants With ≥ 1 log10 Reduction in HIV-1 RNA Viral Load From Baseline at the End of the 1-week Double-blind Treatment Period for All Patients and Within Each Stratum |
.2; .0385 | .0993 |
Summary
This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or more drug classes with limited treatment options).The options may be limited as a result of drug antiviral class cross-resistance or documented treatment intolerance.
Eligibility Criteria
Inclusion Criteria
- Males and females, age ≥ 18 years
- Exclusive CCR5-tropic virus at Screening Visit
- 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 options. The options may be limited as a result of drug antiretroviral class cross-resistance or documented treatment intolerance.
- 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 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 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 (NCT02483078). 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.