HIV InfectionsPhase 1NCT00110591
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
A Phase 1 study testing PRO 140 in people with HIV Infections, run by CytoDyn, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion. Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- PRO 140
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2004to 31 Mar 2008
- Phase
- Phase 1
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not more than 20% below or 20% above ideal weight for height and estimated frame size
- Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests
Who cannot join
- History of clinically significant disease
- History of clinically significant allergies, including drug allergy
- Participated in another clinical trial within the 3 months prior to study entry
- HIV infected
- Hepatitis B or C virus infected
- Active significant infection
- Prior exposure, allergy, or known hypersensitivity to PRO 140
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double Blind, Placebo Controlled, Single-Dose, Rising Dose Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO 140 in Healthy Volunteers
The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.
Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.
Read the detailed description
PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infected individuals. The purpose of this study is to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study.
Participants in this study will be randomly assigned to receive a single dose of one of several possible doses of PRO 140 or placebo. Participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. Follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams, electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.
- Conditions
- HIV Infections
- Being tested
- PRO 140
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO 140Drug
Also called Humanized monoclonal antibody to CCR5
Monoclonal antibody to CCR5
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intravenous placebo for PRO 140 Receives: Drug: PRO 140 |
| PRO 140 dose 1 | Experimental | 0.1 mg/kg PRO 140 by intravenous infusion Receives: Drug: PRO 140 |
| PRO 140 dose 2 | Experimental | 0.5 mg/kg PRO 140 by intravenous infusion Receives: Drug: PRO 140 |
| PRO 140 dose 3 | Experimental | 2.0 mg/kg PRO 140 by intravenous infusion Receives: Drug: PRO 140 |
| PRO 140 dose 4 | Experimental | 5.0 mg/kg PRO 140 by intravenous infusion Receives: Drug: PRO 140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of PRO 140
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2005 (estimated)
- Study start16 Apr 2004
- Primary completion7 Nov 2005
- Study completion31 Mar 2008
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 HIV InfectionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoDyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Olson, PhD, Study chair, Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110591
- Sponsor's protocol ID
- 5R44AI046871-04
- Other IDs
- PRO140-1101
- Status last verified
- Feb 2023
- First submitted
- 10 May 2005
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double Blind, Placebo Controlled, Single-Dose, Rising Dose Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO 140 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00110591
- Acronym / sponsor ID
- 5R44AI046871-04
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CytoDyn, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2004
- Primary completion
- 7 Nov 2005 (actual)
- Study completion
- 31 Mar 2008 (actual)
- First posted
- 11 May 2005 (estimated)
- Results
- Posted 14 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.
Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.
Detailed description
PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infected individuals. The purpose of this study is to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study.
Participants in this study will be randomly assigned to receive a single dose of one of several possible doses of PRO 140 or placebo. Participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. Follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams, electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PRO 140Intravenous placebo for PRO 140 |
| PRO 140 dose 1 | Experimental | Drug: PRO 1400.1 mg/kg PRO 140 by intravenous infusion |
| PRO 140 dose 2 | Experimental | Drug: PRO 1400.5 mg/kg PRO 140 by intravenous infusion |
| PRO 140 dose 3 | Experimental | Drug: PRO 1402.0 mg/kg PRO 140 by intravenous infusion |
| PRO 140 dose 4 | Experimental | Drug: PRO 1405.0 mg/kg PRO 140 by intravenous infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Not more than 20% below or 20% above ideal weight for height and estimated frame size
- Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests
Key exclusion criteria (7 listed)
- History of clinically significant disease
- History of clinically significant allergies, including drug allergy
- Participated in another clinical trial within the 3 months prior to study entry
- HIV infected
- Hepatitis B or C virus infected
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 140Also: Humanized monoclonal antibody to CCR5Monoclonal antibody to CCR5 | Drug | PRO 140 dose 1, PRO 140 dose 2, PRO 140 dose 3, PRO 140 dose 4, Placebo |
Primary outcome
Safety and Tolerability of PRO 140
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William Olson, PhD study chair
Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRO 140 in people with HIV Infections, run by CytoDyn, Inc. at 1 site 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 2 inclusion and 7 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 14 Mar 2023). 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?
Safety and Tolerability of PRO 140 (time frame: 60 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 14 Mar 2023.