Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02859961 · ClinicalTrials.gov registry record · Phase 2
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
A Phase 2 study, sponsored by CytoDyn.
- Completed
- Registry status
- Phase 2
- Development phase
- 562
- Enrollment target
NCT02859961: Completed Phase 2 study, sponsored by CytoDyn.
NCT02859961 is a Phase 2 study that has completed, run by CytoDyn. The registered enrollment target is 562 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (323% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02859961, a Phase 2 study, has completed, sponsored by CytoDyn.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 562 participants
- Enrollment target
Study 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.
Primary Outcome
The proportion of participants experiencing virologic failure was analyzed and reported. Virological failure is defined as two consecutive plasma HIV-1 RNA levels of \>= 200 copies/mL.
Interventions
- DRUG PRO 140 (350 mg)
- DRUG PRO 140 (525 mg)
- DRUG PRO 140 (700 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 2 |
What the finished NCT02859961 record still lists
NCT02859961 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (323% higher).
The record links to 0 conditions, and to 3 interventions - of which PRO 140 (350 mg) is the first listed.
NCT02859961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02859961 about?
NCT02859961 is a clinical study titled "Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection". 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 s...
What is the current status of trial NCT02859961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 562 participants. The study started on 2016-12-07. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT02859961?
The interventions under investigation include: PRO 140 (350 mg) (DRUG), PRO 140 (525 mg) (DRUG), PRO 140 (700 mg) (DRUG).
Who is sponsoring clinical trial NCT02859961?
This trial is sponsored by CytoDyn, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02859961's enrollment target sits among peer trials
562 60th of 2000 higher than 1,941 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07007065 · 561 participants · Phase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
- NCT06146725 · 564 participants
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
- NCT06188520 · 564 participants · Phase 1
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
- NCT06628453 · 564 participants · NA
CGM for Management of Type 2 Diabetes in Pregnancy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI