HIV -1 InfectionPhase 2NCT00642707
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
A Phase 2 study testing PRO 140 (humanized monoclonal antibody to CCR5) in people with HIV -1 Infection and HIV Infections, run by CytoDyn, Inc. at 1 site in United States.
Trial summary
The purpose of this study is: 1. To assess the antiviral activity of PRO 140 2. To assess the safety and tolerability of PRO 140 3. To generate additional PK, PD and safety data of PRO 140 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV -1 Infection, HIV Infections
- What is being tested?
- PRO 140 (humanized monoclonal antibody to CCR5)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Nov 2008
- Phase
- Phase 2
- 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 \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
- Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
- Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
- Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
- Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
- Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit \& a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, \& be non-lactating. Male \& female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.
Who cannot join
- CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
- Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
- History of active hepatitis within the previous 24 wks
- Prior use of any entry, attachment, CCR5 co-receptor 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
1 site in 1 country.
United States1 site
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, 10591
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
The purpose of this study is:
- To assess the antiviral activity of PRO 140
- To assess the safety and tolerability of PRO 140
- To generate additional PK, PD and safety data of PRO 140
- Conditions
- HIV -1 Infection, HIV Infections
- Being tested
- PRO 140 (humanized monoclonal antibody to CCR5), Placebo Comparator
- Keywords
- HIV, Treatment Naïve
- 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 140 (humanized monoclonal antibody to CCR5)Drug
Placebo ComparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | PRO 140 for three single SC doses: Days 1, 8, and 15 Receives: Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
| Arm 2 | Active comparator | PRO 140 for three single SC doses: Days 1, 8 and 15 Receives: Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
| Arm 3 | Active comparator | PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8 Receives: Drug: PRO 140 (humanized monoclonal antibody to CCR5) |
| Arm 4 | Placebo comparator | PBO for three single SC doses: Days 1, 8 and 15 Receives: Drug: Placebo Comparator |
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 Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 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 posted25 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV -1 InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoDyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Morris, MD, PhD, Study director, Progenics Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642707
- Sponsor's protocol ID
- PRO 140 2101
- Status last verified
- Dec 2015
- First submitted
- 21 Mar 2008
- Last updated
- 14 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jacobson JM, Thompson MA, Lalezari JP, Saag MS, Zingman BS, D'Ambrosio P, Stambler N, Rotshteyn Y, Marozsan AJ, Maddon PJ, Morris SA, Olson WC. Anti-HIV-1 activity of weekly or biweekly treatment with subcutaneous PRO 140, a CCR5 monoclonal antibody. J Infect Dis. 2010 May 15;201(10):1481-7. doi: 10.1086/652190.
PubMed 20377413
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
- ClinicalTrials.gov ID
- NCT00642707
- Acronym / sponsor ID
- PRO 140 2101
- Conditions
- HIV -1 Infection, HIV Infections
- Keywords
- HIV, Treatment Naïve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CytoDyn, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 31 May 2013
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 this study is:
- To assess the antiviral activity of PRO 140
- To assess the safety and tolerability of PRO 140
- To generate additional PK, PD and safety data of PRO 140
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: PRO 140 (humanized monoclonal antibody to CCR5)PRO 140 for three single SC doses: Days 1, 8, and 15 |
| Arm 2 | Active comparator | Drug: PRO 140 (humanized monoclonal antibody to CCR5)PRO 140 for three single SC doses: Days 1, 8 and 15 |
| Arm 3 | Active comparator | Drug: PRO 140 (humanized monoclonal antibody to CCR5)PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8 |
| Arm 4 | Placebo comparator | Drug: Placebo ComparatorPBO for three single SC doses: Days 1, 8 and 15 |
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 \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
- Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
- Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
- Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
Key exclusion criteria (5 listed)
- CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
- Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
- History of active hepatitis within the previous 24 wks
- Prior use of any entry, attachment, CCR5 co-receptor 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.
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 (humanized monoclonal antibody to CCR5) | Drug | Arm 1, Arm 2, Arm 3 |
| Placebo Comparator | Drug | Arm 4 |
Primary outcome
Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
Time frame: 59 days
The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection [LLD] = 48 copies/mL).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20377413Jacobson JM, Thompson MA, Lalezari JP, Saag MS, Zingman BS, D'Ambrosio P, Stambler N, Rotshteyn Y, Marozsan AJ, Maddon PJ, Morris SA, Olson WC. Anti-HIV-1 activity of weekly or biweekly treatment with subcutaneous PRO 140, a CCR5 monoclonal antibody. J Infect Dis. 2010 May 15;201(10):1481-7. doi: 10.1086/652190.
- Related InfoLink provided by the sponsor.
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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.
Stephen Morris, MD, PhD study director
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 2 study testing PRO 140 (humanized monoclonal antibody to CCR5) in people with HIV -1 Infection and 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 7 inclusion and 5 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 Jan 2016. 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 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?
Yes. Results are posted in the registry (first posted 31 May 2013). 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?
Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL). (time frame: 59 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642707, which also lists 1 linked publication.
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 Jan 2016.