Phase 3 N=6 Treatment

PRO 140 in Treatment-Experienced HIV-1 Subjects

HIV-1-infection

Bottom Line

View on ClinicalTrials.gov: NCT03902522 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Sep 2025

Primary outcome: Primary: 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 — 0.80 proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: PRO 140 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CytoDyn, Inc.
Primary completion: May 2020

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 Initial 1-week Treatment Period	0.80	—
SECONDARY 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	0.40	—
SECONDARY Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL) at the End of the Initial 1-week Treatment Period	-0.69	—
SECONDARY Percentage of Participants Achieving HIV-1 RNA < 400 Copies/mL at Week 25	5	—
SECONDARY Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 25	3	—
SECONDARY Mean Change From Baseline in HIV-1 RNA Levels (log10 Copies/mL)	-2.29	—
SECONDARY Mean Change From Baseline in CD4 Cell Count at the End of the Initial 1-week Treatment Period	37.4	—
SECONDARY Mean Change From Baseline in CD4 Cell Count at Week 23	123	—

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.

Eligibility Criteria

Inclusion Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03902522). 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.