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Completed Phase 2Phase 3 Interventional Results available

Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection

ClinicalTrials.gov ID: NCT02859961

Public ClinicalTrials.gov record NCT02859961. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 10:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b/3, Multicenter Study to Assess the Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects With CCR5-tropic HIV-1 Infection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02859961
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
CytoDyn, Inc.
Industry
Enrollment
562 participants

Conditions and interventions

Conditions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 6, 2016
Primary completion
Sep 15, 2020
Completion
Dec 6, 2020
Last update posted
Mar 3, 2026

2016 – 2020

United States locations

U.S. sites
12
U.S. states
6
U.S. cities
12
Facility City State ZIP Site status
CD03 Investigational site La Mesa California 91942
CD03 Investigational site Palm Springs California 92262
CD03 Investigational site San Francisco California 94115
CD03 Investigational site New Haven Connecticut 06510
CD03 Investigational site Norwalk Connecticut 06850
CD03 Investigational site Ft. Pierce Florida 34982
CD03 Investigational site Orlando Florida 32803
CD03 Investigational site West Palm Beach Florida 33401
CD03 Investigational site Wichita Kansas 67214
CD03 Investigational site Las Vegas Nevada 89109
CD03 Investigational site New York New York 10011
CD03 Investigational site Syracuse New York 13210

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02859961, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02859961 live on ClinicalTrials.gov.

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