NCT02859961 is a Phase 2, PHASE3 clinical trial of PRO 140 (350 mg) in HIV, sponsored by CytoDyn, Inc..

Who is sponsoring NCT02859961?

NCT02859961 is sponsored by CytoDyn, Inc..

What drugs are being tested in NCT02859961?

Interventions in NCT02859961: PRO 140 (350 mg), PRO 140 (525 mg), PRO 140 (700 mg).

Is NCT02859961 still recruiting?

NCT02859961 is currently completed. Last updated 4 March 2026.

Are results published for NCT02859961?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-03-04 · How we verify

NCT02859961

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Results posted Last updated 4 March 2026

What this trial tests

Phase 2, PHASE3 trial testing PRO 140 (350 mg) in HIV in 562 participants. Completed in 7 December 2020.

Timeline

7 December 2016

Primary endpoint
16 September 2020

7 December 2020

Quick facts

Lead sponsor	CytoDyn, Inc.
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	562
Start date	7 December 2016
Primary completion	16 September 2020
Estimated completion	7 December 2020
Sites	12 locations across United States

Drugs / interventions tested

PRO 140 (350 mg) — full drug profile →
PRO 140 (525 mg) — full drug profile →
PRO 140 (700 mg) — full drug profile →

Conditions studied

HIV — all drugs for HIV →

Sponsor

CytoDyn, Inc. — full company profile →

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure Primary · From T1 (first treatment administration) to week 48 (T48).

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.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	0.23
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	0.43
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	0.45

Proportion of Participants Experiencing Virologic Failure While on PRO 140 Monotherapy Regimen Secondary · From T1 (first treatment administration) to week 48 (T48).

Proportion of participants experiencing virologic failure while on PRO 140 monotherapy arm of the study.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	0.66
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	0.42
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	0.41

Time to Virologic Failure After Initiating PRO 140 Monotherapy Secondary · From T1 (first treatment administration) to week 48 (T48).

The average time to virologic failure after initiating PRO 140 monotherapy was measured in days for confirmed viral load. For the censored subjects (i.e. subjects who did not have an event) the date of event was the time of the last visit date. Virological failure is defined as two consecutive plasma HIV-1 RNA levels of \>= 200 copies/mL.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	136.9	± 115.5
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	197.7	± 132.4
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	200.6	± 133.5

Proportion of Participants Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure. Secondary · From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).

Virologic suppression was defined as plasma HIV-1 RNA levels \< 50 copies/mL as quantified by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR) assay.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	0.92
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	0.79

Time to Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure Secondary · From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).

Virologic suppression was defined as plasma HIV-1 RNA levels \< 50 copies/mL as quantified by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR) assay.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	78.6	± 55.12
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	60.89	± 60.33

Proportion of Participants With Viral Suppression (HIV-1 RNA < 50 Copies/mL) at Week 48 From the Start of PRO 140 Treatment Phase. Secondary · From T1 (first treatment administration) to week 48 (T48).

Virologic suppression was defined as plasma HIV-1 RNA levels \< 50 copies/mL as quantified by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR) assay.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	0.33
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	0.54
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	0.41

Measurement of Treatment Adherence to the PRO 140 Monotherapy Regimen Secondary · From T1 (first treatment administration) to week 25 (T25).

Treatment adherence in the Safety Population for all three treatment groups is provided. Measurement is proportion of subjects that reached treatment week 25 (T25)

Group	Value	95% CI
Part1 - 350 mg Weekly Injections of PRO 140, Group A	111
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	116
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	54

Total Time That Participants Remain Off Combination ART Regimen, Defined as the Time Between Start of PRO 140 Monotherapy and Restart of Combination ART Regimen Secondary · From T1 (first treatment administration) to last visit, up to 20 months.

Total time that participants remain off combination ART regimen will be calculated, defined as the time between start of PRO 140 monotherapy and restart of combination ART Regimen.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	201.53	± 131.82
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	250.48	± 164.43
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	273.25	± 167.63

Mean Change in CD4 Cell Count, at Each Visit Within the Treatment Phase Secondary · From T1 (first treatment administration) to week 48 (T48).

Mean change in CD4 cell count from baseline to final visit for each participant within the Treatment Phase was calculated and summarized. Visit 48 values were imputed using the last observation carried forward if missing.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	-41.1	± 219.3
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	-7.4	± 217.3
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	7.6	± 245.4

Proportion of Participants Within Each Treatment Group Experiencing Emerging Resistance Secondary · From T1 (first treatment administration) to VF visit (up to 7 months).

Proportion of participants experiencing emerging resistance exhibited by fold increase (\>= 3-fold increase) in maraviroc and PRO 140 FC (IC90 relative to wild-type virus) between baseline and the time of virologic failure, as a measure of post-baseline phenotypic resistance.

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	0.23
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	0.13
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	0.13

Mean HIV-1 RNA Concentrations in CSF in Central Nervous System (CNS) Sub-study Secondary · From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).

Central Nervous System (CNS) sub-study Data: mean level of HIV-1 RNA in CSF (cerebrospinal fluid) at T1 (prior to first dose of PRO 140), T4, and VF visits for each treatment group.

T1 (prior to first dose) visit

Group	Value	95% CI
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	1.56	± 5.60
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	1.51	± 4.23

T4 visit

Group	Value	95% CI
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	1.90	± 11.93
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	1.60	± 3.57

VF visit

Group	Value	95% CI
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	1	± 0
Part 1 - 700 mg Weekly Injections of PRO 140, Group C	20.1	± 17.6

Mean PRO 140 Concentration in Plasma for Central Nervous System (CNS) Sub-study Secondary · From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).

PRO 140 concentrations were measured in plasma for a subset of participants at T1, T4, and VF timepoints. Participants contributed data only at timepoints where valid measurements were available. Timepoints with missing or invalid data were excluded.

Visit T1

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	80	± 0
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	80	± 0
Part1 - 700 mg Weekly Injections of PRO 140, Group C	80	± 0

Visit T4

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	15861.03	± 9605.10
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	21126.59	± 8953.93
Part1 - 700 mg Weekly Injections of PRO 140, Group C	30672.09	± 19165.06

Visit VF

Group	Value	95% CI
Part 1 - 350 mg Weekly Injections of PRO 140, Group A	1536.50	± 3501.59
Part 1 - 525 mg Weekly Injections of PRO 140, Group B	31713.25	± 16122.03
Part1 - 700 mg Weekly Injections of PRO 140, Group C	16278.38	± 24824.48

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from the time of the first treatment visit and continued up until the final study visit, up to 22 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 - 350 mg Weekly Injections of PRO 140, Group A

Serious: 16/226 (7%)

Deaths: 1/226

Part 1 - 525 mg Weekly Injections of PRO 140, Group B

Serious: 12/205 (6%)

Deaths: 1/205

Part 1 - 700 mg Weekly Injections of PRO 140, Group C

Serious: 7/131 (5%)

Deaths: 1/131

Part 2 - Group A

Serious: 4/69 (6%)

Deaths: 0/69

Part 2 - Group B

Serious: 3/65 (5%)

Deaths: 0/65

Serious adverse events (41 terms)

Reaction	System	Part 1 - 350 mg Weekly Inj…	Part 1 - 525 mg Weekly Inj…	Part 1 - 700 mg Weekly Inj…	Part 2 - Group A	Part 2 - Group B
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—	—	—
Gastroenteritis	Gastrointestinal disorders	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—
Coronary Artery Disease	Cardiac disorders	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—
Gastroenteritis shigella	Infections and infestations	—	—	—	—	—
Klebsiella sepsis	Infections and infestations	—	—	—	—	—
Localised infection	Infections and infestations	—	—	—	—	—
Meningitis aseptic	Infections and infestations	—	—	—	—	—
Meningitis bacterial	Infections and infestations	—	—	—	—	—
Craniocerebral injury	Injury, poisoning and procedural complications	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Alcoholic seizure	Nervous system disorders	—	—	—	—	—
Seizures	Nervous system disorders	—	—	—	—	—
Subarachnoid haemorrhage	Nervous system disorders	—	—	—	—	—
Hallucination	Psychiatric disorders	—	—	—	—	—
Skin lesion	Skin and subcutaneous tissue disorders	—	—	—	—	—
Multiple organ failure	General disorders	—	—	—	—	—
Cholecystectomy	Surgical and medical procedures	—	—	—	—	—

Other adverse events (16 terms — click to expand)

Reaction	System	Part 1 - 350 mg Weekly Inj…	Part 1 - 525 mg Weekly Inj…	Part 1 - 700 mg Weekly Inj…	Part 2 - Group A	Part 2 - Group B
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Injection site haemorrhage	General disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—
Drug abuse	Psychiatric disorders	—	—	—	—	—

Most-reported serious reactions: Abdominal Pain Upper, Gastroenteritis, Cerebrovascular accident, Coronary Artery Disease, Intestinal obstruction, Pancreatitis acute, Small intestinal obstruction, Appendicitis.

Data from ClinicalTrials.gov NCT02859961 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Antibodies to watch in 2018.
Kaplon H, Reichert JM. · · 2018 · cited 179× · PMID 29300693 · DOI 10.1080/19420862.2018.1415671
Antibody therapies for the prevention and treatment of viral infections.
Salazar G, Zhang N, Fu TM, An Z. · · 2017 · cited 138× · PMID 29263875 · DOI 10.1038/s41541-017-0019-3
Repurposing anticancer drugs for the management of COVID-19.
El Bairi K, Trapani D, Petrillo A, Le Page C, et al · · 2020 · cited 59× · PMID 33125946 · DOI 10.1016/j.ejca.2020.09.014
Alternative Routes of Administration for Therapeutic Antibodies-State of the Art.
Pitiot A, Heuzé-Vourc'h N, Sécher T. · · 2022 · cited 45× · PMID 36134952 · DOI 10.3390/antib11030056
Advances in Long-Acting Agents for the Treatment of HIV Infection.
Rana AI, Castillo-Mancilla JR, Tashima KT, Landovitz RL. · · 2020 · cited 38× · PMID 32180205 · DOI 10.1007/s40265-020-01284-1
New genetic and epigenetic insights into the chemokine system: the latest discoveries aiding progression toward precision medicine.
Xu H, Lin S, Zhou Z, Li D, et al · · 2023 · cited 37× · PMID 37198402 · DOI 10.1038/s41423-023-01032-x
Strategies to overcome HIV drug resistance-current and future perspectives.
Temereanca A, Ruta S. · · 2023 · cited 35× · PMID 36876064 · DOI 10.3389/fmicb.2023.1133407

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02859961 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CytoDyn, Inc.
Last refreshed: 4 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02859961.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02859961

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (41 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for HIV

Other CytoDyn, Inc. trials

Verify against primary sources