HIVPhase 2/3NCT02859961
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
A Phase 2/3 study testing PRO 140 (350 mg), PRO 140 (525 mg) and PRO 140 (700 mg) in people with HIV, run by CytoDyn, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- PRO 140 (350 mg), PRO 140 (525 mg) and PRO 140 (700 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 12 sitesUnited States
- Study dates
- 7 Dec 2016to 7 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age ≥18 years
- Receiving combination antiretroviral therapy for last 24 weeks
- No change in ART within last 4 weeks prior to Screening Visit
- Subject has two or more potential alternative approved ART drug options to consider.
- Exclusive CCR5-tropic virus at Screening Visit
- Plasma HIV-1 RNA < 50 copies/mL at Screening Visit
Show all 19Show fewer
- CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy
- CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at 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 x upper limit of normal (ULN)
- Serum aspartate transaminase (SGOT/AST) < 5 x ULN
- Bilirubin (total) < 2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
- Creatinine ≤ 1.5 x ULN
- Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception during the course of the study.
- Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
Who cannot join
- CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay
- Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
- Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
- Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Unexplained fever or clinically significant illness within 1 week prior to the first study dose
Show all 20Show fewer
- Any vaccination within 2 weeks prior to the first study dose or during the study.
- Subjects who have failed on a maraviroc containing regimen.
- Subjects weighing < 35kg
- History of anaphylaxis to any oral or parenteral drugs
- History of Bleeding Disorder or patients on anti-coagulant therapy
- Participation in an experimental drug trial(s) within 30 days of the Screening Visit
- Any known allergy or antibodies to the study drug or excipients
- Treatment with any of the following:
- Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
- Immunosuppressants within 60 days prior to the screening visit
- Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit
- Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
CD03 Investigational site
Ft. Pierce, Florida, 34982
CD03 Investigational site
La Mesa, California, 91942
CD03 Investigational site
Las Vegas, Nevada, 89109
CD03 Investigational site
New Haven, Connecticut, 06510
CD03 Investigational site
New York, New York, 10011
CD03 Investigational site
Norwalk, Connecticut, 06850
CD03 Investigational site
Orlando, Florida, 32803
CD03 Investigational site
Palm Springs, California, 92262
CD03 Investigational site
San Francisco, California, 94115
CD03 Investigational site
Syracuse, New York, 13210
CD03 Investigational site
West Palm Beach, Florida, 33401
CD03 Investigational site
Wichita, Kansas, 67214
About this study
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
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.
Read the detailed description
The primary objective is to assess the treatment strategy of using PRO 140 SC as long-acting, single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection. In addition, the prognostic factors of therapeutic success of PRO 140 monotherapy will be evaluated.
The secondary objective of the trial is to assess the clinical efficacy, safety and tolerability parameters following substitution of combination antiretroviral therapy with weekly PRO 140 monotherapy.
- Conditions
- HIV
- Being tested
- PRO 140 (350 mg), PRO 140 (525 mg), PRO 140 (700 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO 140 (350 mg)Drug
Also called Leronlimab
PRO 140 350 mg (175 mg/mL) SC injection per week
PRO 140 (525 mg)Drug
Also called Leronlimab
PRO 140 525 mg (175 mg/mL) SC injection per week
PRO 140 (700 mg)Drug
Also called Leronlimab
PRO 140 700 mg (175 mg/mL) SC injection per week
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - 350 mg weekly injections of PRO 140, no VF (Group A) | Experimental | 350 mg SC injections of PRO 140 per week, patients who had no Virologic Failure (VF) Receives: Drug: PRO 140 (350 mg) |
| Part 1 - 525 mg weekly injections of PRO 140, no VF (Group B) | Experimental | 525 mg SC injections of PRO 140 per week, patients who had no Virologic Failure (VF) Receives: Drug: PRO 140 (525 mg) |
| Part 1 - 700 mg weekly injections of PRO 140 (Group C) | Experimental | 700 mg SC injections of PRO 140 per week Receives: Drug: PRO 140 (700 mg) |
| Part 2 - Rescue Arm for Group A, 525 mg PRO 140 | Experimental | 525 mg SC injections of PRO 140 per week after experiencing virologic failure on 350 mg dose Receives: Drug: PRO 140 (525 mg) |
| Part 2 - Rescue Arm for Group B, 700 mg PRO 140 | Experimental | 700 mg SC injections of PRO 140 per week after experiencing virologic failure on 525 mg dose Receives: Drug: PRO 140 (700 mg) |
| Part 2 - Rescue Arm for Group A, 700 mg PRO 140 | Experimental | 700 mg SC injections of PRO 140 per week after experiencing virologic failure on 350 mg dose Receives: Drug: PRO 140 (700 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure
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.
Measured: From T1 (first treatment administration) to week 48 (T48).
Secondary outcomes (13)
Proportion of Participants Experiencing Virologic Failure While on PRO 140 Monotherapy Regimen
Proportion of participants experiencing virologic failure while on PRO 140 monotherapy arm of the study.
Measured: From T1 (first treatment administration) to week 48 (T48).
Time to Virologic Failure After Initiating PRO 140 Monotherapy
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.
Measured: From T1 (first treatment administration) to week 48 (T48).
Proportion of Participants Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure.
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.
Measured: From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).
Time to Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure
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.
Measured: From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).
Proportion of Participants With Viral Suppression (HIV-1 RNA < 50 Copies/mL) at Week 48 From the Start of PRO 140 Treatment Phase.
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.
Measured: From T1 (first treatment administration) to week 48 (T48).
Measurement of Treatment Adherence to the PRO 140 Monotherapy Regimen
Treatment adherence in the Safety Population for all three treatment groups is provided. Measurement is proportion of subjects that reached treatment week 25 (T25)
Measured: From T1 (first treatment administration) to week 25 (T25).
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
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.
Measured: From T1 (first treatment administration) to last visit, up to 20 months.
Mean Change in CD4 Cell Count, at Each Visit Within the Treatment Phase
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.
Measured: From T1 (first treatment administration) to week 48 (T48).
Proportion of Participants Within Each Treatment Group Experiencing Emerging Resistance
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.
Measured: From T1 (first treatment administration) to VF visit (up to 7 months).
Mean HIV-1 RNA Concentrations in CSF in Central Nervous System (CNS) Sub-study
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.
Measured: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).
Mean PRO 140 Concentration in Plasma for Central Nervous System (CNS) Sub-study
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.
Measured: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).
Mean PRO 140 Concentrations in CSF for Central Nervous System (CNS) Sub-study
PRO 140 concentrations were measured in CSF (cerebrospinal fluid) in a subset of participants at visits T1, T4, and VF.
Measured: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).
Mean HIV-1 RNA Concentrations in Genital Secretion in Genitourinary (GU) Sub-study
Level of HIV-1 RNA in genital secretion at T1 (prior to first dose of PRO 140), T4, and T16 visits.
Measured: From T1 (first treatment administration), T4 visit (week 4), and T16 visit (up to 16 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start7 Dec 2016
- Primary completion16 Sep 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoDyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Lalezari, MD, Study director, CytoDyn, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859961
- Sponsor's protocol ID
- PRO 140_CD03
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2016
- Last updated
- 4 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02859961
- Acronym / sponsor ID
- PRO 140_CD03
- Conditions
- HIV
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- CytoDyn, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Posted 4 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to assess the treatment strategy of using PRO 140 SC as long-acting, single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection. In addition, the prognostic factors of therapeutic success of PRO 140 monotherapy will be evaluated.
The secondary objective of the trial is to assess the clinical efficacy, safety and tolerability parameters following substitution of combination antiretroviral therapy with weekly PRO 140 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 - 350 mg weekly injections of PRO 140, no VF (Group A) | Experimental | Drug: PRO 140 (350 mg)350 mg SC injections of PRO 140 per week, patients who had no Virologic Failure (VF) |
| Part 1 - 525 mg weekly injections of PRO 140, no VF (Group B) | Experimental | Drug: PRO 140 (525 mg)525 mg SC injections of PRO 140 per week, patients who had no Virologic Failure (VF) |
| Part 1 - 700 mg weekly injections of PRO 140 (Group C) | Experimental | Drug: PRO 140 (700 mg)700 mg SC injections of PRO 140 per week |
| Part 2 - Rescue Arm for Group A, 525 mg PRO 140 | Experimental | Drug: PRO 140 (525 mg)525 mg SC injections of PRO 140 per week after experiencing virologic failure on 350 mg dose |
| Part 2 - Rescue Arm for Group B, 700 mg PRO 140 | Experimental | Drug: PRO 140 (700 mg)700 mg SC injections of PRO 140 per week after experiencing virologic failure on 525 mg dose |
| Part 2 - Rescue Arm for Group A, 700 mg PRO 140 | Experimental | Drug: PRO 140 (700 mg)700 mg SC injections of PRO 140 per week after experiencing virologic failure on 350 mg dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males and females, age ≥18 years
- Receiving combination antiretroviral therapy for last 24 weeks
- No change in ART within last 4 weeks prior to Screening Visit
- Subject has two or more potential alternative approved ART drug options to consider.
- Exclusive CCR5-tropic virus at Screening Visit
Key exclusion criteria (20 listed)
- CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay
- Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
- Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
- Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO 140 (350 mg)Also: LeronlimabPRO 140 350 mg (175 mg/mL) SC injection per week | Drug | Part 1 - 350 mg weekly injections of PRO 140, no VF (Group A) |
| PRO 140 (525 mg)Also: LeronlimabPRO 140 525 mg (175 mg/mL) SC injection per week | Drug | Part 1 - 525 mg weekly injections of PRO 140, no VF (Group B), Part 2 - Rescue Arm for Group A, 525 mg PRO 140 |
| PRO 140 (700 mg)Also: LeronlimabPRO 140 700 mg (175 mg/mL) SC injection per week | Drug | Part 1 - 700 mg weekly injections of PRO 140 (Group C), Part 2 - Rescue Arm for Group A, 700 mg PRO 140, Part 2 - Rescue Arm for Group B, 700 mg PRO 140 |
Primary outcome
Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure
Time frame: 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.
13 secondary outcomes
Proportion of Participants Experiencing Virologic Failure While on PRO 140 Monotherapy Regimen
Time frame: From T1 (first treatment administration) to week 48 (T48).
Time to Virologic Failure After Initiating PRO 140 Monotherapy
Time frame: From T1 (first treatment administration) to week 48 (T48).
Proportion of Participants Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure.
Time frame: From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).
Time to Achieving Viral Suppression (HIV-1 RNA < 50 Copies/mL) After Experiencing Virologic Failure
Time frame: From T1 (first treatment administration) to subsequent visit when viral re-suppression achieved (up to 52 weeks).
Proportion of Participants With Viral Suppression (HIV-1 RNA < 50 Copies/mL) at Week 48 From the Start of PRO 140 Treatment Phase.
Time frame: From T1 (first treatment administration) to week 48 (T48).
Measurement of Treatment Adherence to the PRO 140 Monotherapy Regimen
Time frame: From T1 (first treatment administration) to week 25 (T25).
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
Time frame: From T1 (first treatment administration) to last visit, up to 20 months.
Mean Change in CD4 Cell Count, at Each Visit Within the Treatment Phase
Time frame: From T1 (first treatment administration) to week 48 (T48).
Proportion of Participants Within Each Treatment Group Experiencing Emerging Resistance
Time frame: From T1 (first treatment administration) to VF visit (up to 7 months).
Mean HIV-1 RNA Concentrations in CSF in Central Nervous System (CNS) Sub-study
Time frame: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).
Mean PRO 140 Concentration in Plasma for Central Nervous System (CNS) Sub-study
Time frame: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).
Mean PRO 140 Concentrations in CSF for Central Nervous System (CNS) Sub-study
Time frame: From T1 (first treatment administration), T4 (week 4), and VF visit (up to 7 months).
Mean HIV-1 RNA Concentrations in Genital Secretion in Genitourinary (GU) Sub-study
Time frame: From T1 (first treatment administration), T4 visit (week 4), and T16 visit (up to 16 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Lalezari, MD study director
CytoDyn, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRO 140 (350 mg), PRO 140 (525 mg) and PRO 140 (700 mg) in people with HIV, run by CytoDyn, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Who Remain on PRO 140 Monotherapy Regimen at the End of Week 48 Without Experiencing Virologic Failure (time frame: From T1 (first treatment administration) to week 48 (T48).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.