NCT03902522

PRO 140 in Treatment-Experienced HIV-1 Subjects

A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial With PRO 140 in Treatment-Experienced HIV-1 Subjects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRO 140, in combination with other antiretroviral agents, is indicated for treatment experienced adult HIV-1 patients infected with CCR5-tropic virus (virus that uses the chemokine receptor type 5 to enter the cell). These patients must demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy and have documented genotypic or phenotypic resistance to at least one ART drug within three drug classes (or within two or more drug classes with 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. 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 drug classes with limited treatment option). The primary objectives of the trial are to assess the efficacy, clinical safety and tolerability parameters of PRO 140 in combination with failing ART during the initial one-week treatment period, and in combination with Optimized Background Therapy during the subsequent 24-week treatment period.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	PRO 140	2 injections of PRO 140 (2 X 2 mL/inj.) Subjects who were previously enrolled and receiving 350 mg dose had the option to move to the 700mg dose for the remainder of the trial.

Timeline

• Start date: 2018-06-25
• Primary completion: 2020-05-18
• Completion: 2020-05-18
• First posted: 2019-04-04
• Last updated: 2025-09-16
• Results posted: 2025-09-16

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study