HIVPhase 2NCT02257788
PRO 140 for Human Immunodeficiency Virus Infection
A Phase 2 study testing PRO 140 in people with HIV, run by Drexel University at 7 sites in United States.
Trial summary
PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2014to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
- Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
- Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- Clinically normal resting 12-lead ECG at screening visit
- Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through three weeks after the last administered subcutaneous dose of PRO 140.
Who cannot join
- CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
- Chronic hepatitis
- Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
- Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado Denver (Colorado ACTU)
Denver, Colorado, 80045
University of Texas Health Science Center at Houston (Houston AIDS Research team (HART)
Houston, Texas, 77030
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Rochester Medical Center
Rochester, New York, 14642
Washington University in St. Louis
St Louis, Missouri, 63110
Stanford University (Stanford AIDS Clinical Trials Unit)
Stanford, California, 94304
About this study
Official title: PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.
Read the detailed description
Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.
- Conditions
- HIV
- Being tested
- PRO 140
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO 140Biological
Humanized monoclonal antibody to CCR5
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Active comparator | PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) Receives: Biological: PRO 140 |
| Treatment Arm 2 | Active comparator | PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) Receives: Biological: PRO 140 |
| Treatment Arm 3 | Active comparator | PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) Receives: Biological: PRO 140 |
| Treatment Arm 4 | Active comparator | PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) Receives: Biological: PRO 140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change in viral load following initiation of different dosing regimens of PRO140
Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL
Measured: 59 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Unlikely to achieve targeted accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Jacobson, MD, Study chair, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257788
- Sponsor's protocol ID
- 1210001606
- Other IDs
- 5U01AI095085-03
- Status last verified
- Mar 2017
- First submitted
- 2 Oct 2014
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
- ClinicalTrials.gov ID
- NCT02257788
- Acronym / sponsor ID
- 1210001606
- Conditions
- HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unlikely to achieve targeted accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.
Detailed description
Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Active comparator | Biological: PRO 140PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
| Treatment Arm 2 | Active comparator | Biological: PRO 140PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
| Treatment Arm 3 | Active comparator | Biological: PRO 140PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
| Treatment Arm 4 | Active comparator | Biological: PRO 140PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females, age ≥18 years
- Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
- Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
- Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
Key exclusion criteria (6 listed)
- CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
- Chronic hepatitis
- Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
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 140Humanized monoclonal antibody to CCR5 | Biological | Treatment Arm 1, Treatment Arm 2, Treatment Arm 3, Treatment Arm 4 |
Primary outcome
Maximum change in viral load following initiation of different dosing regimens of PRO140
Time frame: 59 days
Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
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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.
Jeffrey Jacobson, MD study chair
Drexel University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRO 140 in people with HIV, run by Drexel University at 7 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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximum change in viral load following initiation of different dosing regimens of PRO140 (time frame: 59 days). 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 9 Mar 2017.