Prevention of Infection With HIV-1Phase 1TMB-108NCT01292174
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
A Phase 1 study of Prevention of Infection With HIV-1, run by TaiMed Biologics Inc. at 6 sites in United States.
Trial summary
The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, at one of three… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Infection With HIV-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2011to Sep 2012
- Phase
- Phase 1
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At-risk adult males and females, as assessed by a medical history, physical exam, and laboratory tests
- At least 18 years of age and no greater than 40 years on the day of screening
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed
- Willing to undergo HIV Testing and counseling, and receive HIV test results
- Agrees to use a barrier form of contraception if engaging in sexual activity at any time throughout the study and the follow-up period (males and females) - two reliable forms of contraception, one barrier and one hormonal (e.g., oral contraceptive pill, injectable or implantable contraceptive combined with diaphragm, Intra Uterine Device (IUD), or condoms), must be used if volunteers engage in sexual activity that could result in pregnancy; is anatomically sterile in self or partner; all female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Events and Procedures
Who cannot join
- Confirmed HIV-1 or HIV-2 infection
- Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the trial physician within the last 6 months
- Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
- Any laboratory value of Grade 1 or higher according to the NCI Common Toxicity Criteria
- Confirmed diagnosis of hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies)
- Current confirmed STD infection
Show all 14Show fewer
- Prior receipt of Hepatitis A vaccine by history, or anti-hepatitis A antibodies at screening
- Pregnant, planning a pregnancy during the trial period, or lactating
- Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of study enrollment
- Receipt of blood transfusion or blood products 6 months prior to study drug administration
- Participation in another clinical study of an investigational product currently or within 30 days prior to Screening, or expected participation during this study
- History of severe allergic reactions or known allergy to any component of the study drug
- Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicide attempt in the previous 3 years
- In the opinion of the investigator, unlikely to comply with protocol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Alabama Vaccine Research Center
Birmingham, Alabama, 35294-2050
Research Access Network / The Schrader Clinic
Houston, Texas, 77098
Living Hope Clinical Foundation
Long Beach, California, 90813
ACRIA - AIDS Community Research Initiative of America
New York, New York, 10018
University of Rochester
Rochester, New York, 14642
Quest Clinical Research
San Francisco, California, 94115
About this study
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Sequential Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Ibalizumab in HIV-Negative, At-Risk Volunteers
The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, at one of three dose levels. Drug administration begins at the lowest dose. After 4 of 8 volunteers in the first group have received all study drug injections and have completed 6 additional weeks of follow-up, an independent safety monitoring group will review available data before approving initiation of the next higher dose-group. This process will be repeated prior to initiation of the 3rd and highest dose-group.
All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each to test drug levels.
Read the detailed description
The study is a phase 1, randomized, double-blinded, placebo-controlled, sequential dose-escalation and safety study of ibalizumab in at-risk HIV-negative volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, in one of three groups as defined below:
Group 1: 120 mg sc weekly x 4 weeks, randomized 6:2 with placebo Group 2: 240 mg sc weekly x 4 weeks, randomized 6:2 with placebo Group 3: 480 mg sc weekly x 4 weeks, randomized 6:2 with placebo
Volunteers will be screened up to 42 days prior to enrollment and first drug administration, and will be followed for 26 weeks after the final injection.
All subjects will be expected to participate in two (2) intense PK sampling periods with a duration of 7 days for the first period and 14 days for the second period. During these periods (following Day 0 and following Week 3) subjects will have daily serum concentration and other investigational pharmacokinetic assessments.
All volunteers will be encouraged to participate in an optional collection of genital secretions (semen or vaginal wash) at Week 4.
An independent data safety monitoring board (DSMB) will review study data after four out of eight at-risk HIV-negative volunteers in Group 1 (120 mg dose) have received all study drug injections and completed 6 weeks of follow-up before approving escalation to Group 2 (240 mg dose). The DSMB will also review all available study data from Groups 1, and 2 after four out of eight volunteers in Group 2 have received all study drug injections and completed 6 weeks of follow-up before approving escalation to Group 3 (480 mg dose).
- Conditions
- Prevention of Infection With HIV-1
- Being tested
- ibalizumab (biologic/MAb) for SC Injection or placebo
- Keywords
- HIV prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibalizumab (biologic/MAb) for SC Injection or placeboBiological
Also called formerly TNX-355
ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg
ibalizumab (biologic/MAb) for SC Injection or placeboBiological
Also called formerly TNX-355
ibalizumab or matching placebo administered by subcutaneous injection weekly at 240 mg
ibalizumab (biologic/MAb) for SC Injection or placeboBiological
Also called formerly TNX-355
ibalizumab or matching placebo administered by subcutaneous injection weekly at 480 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - lowest dosage | Experimental | 120 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo Receives: Biological: ibalizumab (biologic/MAb) for SC Injection or placebo |
| Group 2 - middle dosage level | Experimental | 240 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo Receives: Biological: ibalizumab (biologic/MAb) for SC Injection or placebo |
| Group 3 - highest dosage level | Experimental | 480 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo Receives: Biological: ibalizumab (biologic/MAb) for SC Injection or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of subcutaneous administration of ibalizumab in at-risk HIV-negative volunteers
Safety and Tolerability Measures Include:
- Physical examinations
- Vital sign measurements
- Anti-ibalizumab antibody levels (immunogenicity of ibalizumab)
- Clinical laboratory parameters (hematology, serum chemistry and urinalysis)
- Urine or serum pregnancy tests
- Adverse events
- Serious Adverse Events
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Infection With HIV-1Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiMed Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aaron Diamond AIDS Research Center, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Stanley T Lewis, MD, MPH, Study director, TaiMed Biologics, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292174
- Sponsor's protocol ID
- TMB-108
- Acronym
- TMB-108
- Status last verified
- Dec 2012
- First submitted
- 7 Feb 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Sequential Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Ibalizumab in HIV-Negative, At-Risk Volunteers
- ClinicalTrials.gov ID
- NCT01292174
- Acronym / sponsor ID
- TMB-108 / TMB-108
- Conditions
- Prevention of Infection With HIV-1
- Keywords
- HIV prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TaiMed Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Aaron Diamond AIDS Research Center, Bill and Melinda Gates Foundation
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Feb 2011 (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.
The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, at one of three dose levels. Drug administration begins at the lowest dose. After 4 of 8 volunteers in the first group have received all study drug injections and have completed 6 additional weeks of follow-up, an independent safety monitoring group will review available data before approving initiation of the next higher dose-group. This process will be repeated prior to initiation of the 3rd and highest dose-group.
All volunteers will participate in 2 separate intensive blood sampling periods of 7 days each to test drug levels.
Detailed description
The study is a phase 1, randomized, double-blinded, placebo-controlled, sequential dose-escalation and safety study of ibalizumab in at-risk HIV-negative volunteers. The study involves the administration of four total injections of ibalizumab or matching placebo in each volunteer, given once every week, in one of three groups as defined below:
Group 1: 120 mg sc weekly x 4 weeks, randomized 6:2 with placebo Group 2: 240 mg sc weekly x 4 weeks, randomized 6:2 with placebo Group 3: 480 mg sc weekly x 4 weeks, randomized 6:2 with placebo
Volunteers will be screened up to 42 days prior to enrollment and first drug administration, and will be followed for 26 weeks after the final injection.
All subjects will be expected to participate in two (2) intense PK sampling periods with a duration of 7 days for the first period and 14 days for the second period. During these periods (following Day 0 and following Week 3) subjects will have daily serum concentration and other investigational pharmacokinetic assessments.
All volunteers will be encouraged to participate in an optional collection of genital secretions (semen or vaginal wash) at Week 4.
An independent data safety monitoring board (DSMB) will review study data after four out of eight at-risk HIV-negative volunteers in Group 1 (120 mg dose) have received all study drug injections and completed 6 weeks of follow-up before approving escalation to Group 2 (240 mg dose). The DSMB will also review all available study data from Groups 1, and 2 after four out of eight volunteers in Group 2 have received all study drug injections and completed 6 weeks of follow-up before approving escalation to Group 3 (480 mg dose).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - lowest dosage | Experimental | Biological: ibalizumab (biologic/MAb) for SC Injection or placebo120 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo |
| Group 2 - middle dosage level | Experimental | Biological: ibalizumab (biologic/MAb) for SC Injection or placebo240 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo |
| Group 3 - highest dosage level | Experimental | Biological: ibalizumab (biologic/MAb) for SC Injection or placebo480 mg ibalizumab administered by subcutaneous injection weekly for 4 weeks, randomized 6:2 with placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- At-risk adult males and females, as assessed by a medical history, physical exam, and laboratory tests
- At least 18 years of age and no greater than 40 years on the day of screening
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed
- Willing to undergo HIV Testing and counseling, and receive HIV test results
Key exclusion criteria (14 listed)
- Confirmed HIV-1 or HIV-2 infection
- Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the trial physician within the last 6 months
- Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
- Any laboratory value of Grade 1 or higher according to the NCI Common Toxicity Criteria
- Confirmed diagnosis of hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies)
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 |
|---|---|---|
| ibalizumab (biologic/MAb) for SC Injection or placeboAlso: formerly TNX-355ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg | Biological | Group 1 - lowest dosage |
| ibalizumab (biologic/MAb) for SC Injection or placeboAlso: formerly TNX-355ibalizumab or matching placebo administered by subcutaneous injection weekly at 240 mg | Biological | Group 2 - middle dosage level |
| ibalizumab (biologic/MAb) for SC Injection or placeboAlso: formerly TNX-355ibalizumab or matching placebo administered by subcutaneous injection weekly at 480 mg | Biological | Group 3 - highest dosage level |
Primary outcome
To evaluate the safety and tolerability of subcutaneous administration of ibalizumab in at-risk HIV-negative volunteers
Time frame: 30 weeks
Safety and Tolerability Measures Include: * Physical examinations * Vital sign measurements * Anti-ibalizumab antibody levels (immunogenicity of ibalizumab) * Clinical laboratory parameters (hematology, serum chemistry and urinalysis) * Urine or serum pregnancy tests * Adverse events * Serious Adverse Events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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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.
Stanley T Lewis, MD, MPH study director
TaiMed Biologics, USA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Prevention of Infection With HIV-1, run by TaiMed Biologics Inc. at 6 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 6 inclusion and 14 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 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety and tolerability of subcutaneous administration of ibalizumab in at-risk HIV-negative volunteers (time frame: 30 weeks). 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 18 Dec 2012.