HIV-1 InfectionPhase 1/2NCT01092104
A Proof of Concept Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients
A Phase 1/2 study testing TBR-652, TBR-652 50 mg and TBR-652 75 mg in people with HIV-1 Infection, run by Tobira Therapeutics, Inc..
Trial summary
A double-blind, randomized, placebo-controlled, dose-escalating study to assess the antiviral activity, safety, tolerability, and pharmacokinetics (PK) of the CCR5 antagonist TBR 652 monotherapy dosed orally once daily (QD) for 10 days in HIV 1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naïve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- TBR-652, TBR-652 50 mg and TBR-652 75 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Nov 2009
- Phase
- Phase 1/2
- 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
- No clinically significant findings on Screening evaluations (clinical, laboratory, and ECG), which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.
- Antiretroviral treatment-experienced; no antiretroviral therapy for at least 6 weeks prior to study entry.
- CCR5 antagonist therapy naive.
- CD4 cell count >/= 250 cells/mm3 during Screening (within 30 days prior to first dose).
- Two separate qualifying plasma HIV 1 RNA levels >/= 5,000 copies/mL within 45 days prior to first dose.
- Females who are not of reproductive potential (documented to be surgically sterile or postmenopausal [defined as amenorrhea ≥ 1 year and follicle stimulating hormone {FSH} ≥ 30 mU/mL]).
- Females of child-bearing potential may be enrolled following a negative serum pregnancy test. If participating in activity that could lead to pregnancy, males and females shall agree to use two forms of barrier method contraception during the trial and for 2 months after stopping the medication.
Who cannot join
- Presence of CXCR4- or dual/mixed-tropic HIV 1 virus.
- Active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial).
- History of infection with hepatitis B or hepatitis C virus, history of cirrhosis, or any known active or chronic liver disease. NOTE: Hepatitis B vaccinated patients are eligible.
- Serum ALT or AST values greater than Grade 1 or bilirubin values greater than the upper limit of normal (ULN) at Screening.
- History of HIV-2.
- Recent history (< 30 days prior to study drug administration) of clinically significant infection.
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- Pregnant females or females who are breastfeeding.
- Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity within 30 days prior to study drug administration.
- Treatment with any vaccine within 30 days of study drug administration.
- A positive pre-study drug screen, including amphetamines, barbiturates, cocaine, or PCP.
- Anticipated use of antacids during the trial and/or within 7 days prior to first dose of study drug.
- Current alcohol or drug use, which in the expert judgment of the investigator, will interfere with the patient's ability to comply with the protocol requirements.
- Inability, in the opinion of the investigator, to comply with the dosing schedule and protocol evaluations.
- Use of any experimental medications within 4 weeks prior to Screening.
- Current (within 30 days prior to the first dose of study drug) or anticipated use of antimetabolites; alkylating agents; or drugs, herbal preparations, and foods (including grapefruit) known to affect the CYP 3A4 or CYP 2C8 enzymes or P-glycoprotein transporters.
- History of clinically significant hepatic, metabolic, endocrine, renal, hematologic, pulmonary, gastrointestinal, or cardiovascular disorders (including ECG abnormalities).
- Uncontrolled hypertension.
- Presence of a malabsorption syndrome affecting drug absorption (e.g., Crohn's disease, chronic pancreatitis).
- History of malignancy with exception of cured basal or squamous cell carcinoma of the skin.
- Receipt of radiation or cytotoxic chemotherapeutic agents and not recovered from side effects prior to the first dose of study medication.
- Subjects who have used any over-the-counter medications (including phytotherapeutic, herbal, or plant-derived preparations) within 14 days prior to the first dose of study medication, unless approved by the Investigator, or who have used St. John's wort within 21 days prior to the first dose of study drug. (St. John's wort is prohibited during the study.)
- History or presence of an abnormal ECG.
About this study
Official title: A Proof of Concept, Multiple Dose-Escalating Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients
A double-blind, randomized, placebo-controlled, dose-escalating study to assess the antiviral activity, safety, tolerability, and pharmacokinetics (PK) of the CCR5 antagonist TBR 652 monotherapy dosed orally once daily (QD) for 10 days in HIV 1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naïve patients.
- Conditions
- HIV-1 Infection
- Being tested
- TBR-652, TBR-652 Matching Placebo, TBR-652 50 mg, TBR-652 75 mg, TBR-652 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBR-652Drug
TBR-652 25 mg
TBR-652 Matching PlaceboDrug
Matching Placebo
TBR-652 50 mgDrug
TBR-652 50 mg QD for 10 days
TBR-652 75 mgDrug
TBR-652 75 mg QD for 10 days
TBR-652 100 mgDrug
TBR-652 100 mg QD for 10 days
TBR-652 150 mgDrug
TBR-652 150 mg QD for 10 days
| Study group | Role | What they receive |
|---|---|---|
| TBR-652 25 mg QD | Experimental | TBR 25 mg QD for 10 days Receives: Drug: TBR-652 |
| Placebo | Placebo comparator | Matching Placebo QD for 10 days Receives: Drug: TBR-652 Matching Placebo |
| TBR-652 50 mg QD | Experimental | TBR-652 50 mg QD for 10 days Receives: Drug: TBR-652 50 mg |
| TBR-652 75 mg QD | Experimental | TBR-652 75 mg QD for 10 days Receives: Drug: TBR-652 75 mg |
| TBR-652 100 mg QD | Experimental | TBR-652 100 mg QD for 10 days Receives: Drug: TBR-652 100 mg |
| TBR-652 150 mg | Experimental | TBR-652 150 mg QD for 10 days Receives: Drug: TBR-652 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-1 RNA Change from Baseline
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tobira Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092104
- Sponsor's protocol ID
- 652-2-201
- Status last verified
- Jul 2013
- First submitted
- 22 Mar 2010
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lalezari J, Gathe J, Brinson C, Thompson M, Cohen C, Dejesus E, Galindez J, Ernst JA, Martin DE, Palleja SM. Safety, efficacy, and pharmacokinetics of TBR-652, a CCR5/CCR2 antagonist, in HIV-1-infected, treatment-experienced, CCR5 antagonist-naive subjects. J Acquir Immune Defic Syndr. 2011 Jun 1;57(2):118-25. doi: 10.1097/QAI.0b013e318213c2c0.
PubMed 21317794Marier JF, Trinh M, Pheng LH, Palleja SM, Martin DE. Pharmacokinetics and pharmacodynamics of TBR-652, a novel CCR5 antagonist, in HIV-1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naive patients. Antimicrob Agents Chemother. 2011 Jun;55(6):2768-74. doi: 10.1128/AAC.00713-10. Epub 2011 Apr 12.
PubMed 21486960
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept, Multiple Dose-Escalating Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients
- ClinicalTrials.gov ID
- NCT01092104
- Acronym / sponsor ID
- 652-2-201
- Conditions
- HIV-1 Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tobira Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 24 Mar 2010 (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.
A double-blind, randomized, placebo-controlled, dose-escalating study to assess the antiviral activity, safety, tolerability, and pharmacokinetics (PK) of the CCR5 antagonist TBR 652 monotherapy dosed orally once daily (QD) for 10 days in HIV 1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naïve patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TBR-652 25 mg QD | Experimental | Drug: TBR-652TBR 25 mg QD for 10 days |
| Placebo | Placebo comparator | Drug: TBR-652 Matching PlaceboMatching Placebo QD for 10 days |
| TBR-652 50 mg QD | Experimental | Drug: TBR-652 50 mgTBR-652 50 mg QD for 10 days |
| TBR-652 75 mg QD | Experimental | Drug: TBR-652 75 mgTBR-652 75 mg QD for 10 days |
| TBR-652 100 mg QD | Experimental | Drug: TBR-652 100 mgTBR-652 100 mg QD for 10 days |
| TBR-652 150 mg | Experimental | Drug: TBR-652 150 mgTBR-652 150 mg QD for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No clinically significant findings on Screening evaluations (clinical, laboratory, and ECG), which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.
- Antiretroviral treatment-experienced; no antiretroviral therapy for at least 6 weeks prior to study entry.
- CCR5 antagonist therapy naive.
- CD4 cell count >/= 250 cells/mm3 during Screening (within 30 days prior to first dose).
- Two separate qualifying plasma HIV 1 RNA levels >/= 5,000 copies/mL within 45 days prior to first dose.
Key exclusion criteria (22 listed)
- Presence of CXCR4- or dual/mixed-tropic HIV 1 virus.
- Active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial).
- History of infection with hepatitis B or hepatitis C virus, history of cirrhosis, or any known active or chronic liver disease. NOTE: Hepatitis B vaccinated patients are eligible.
- Serum ALT or AST values greater than Grade 1 or bilirubin values greater than the upper limit of normal (ULN) at Screening.
- History of HIV-2.
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 |
|---|---|---|
| TBR-652TBR-652 25 mg | Drug | TBR-652 25 mg QD |
| TBR-652 Matching PlaceboMatching Placebo | Drug | Placebo |
| TBR-652 50 mgTBR-652 50 mg QD for 10 days | Drug | TBR-652 50 mg QD |
| TBR-652 75 mgTBR-652 75 mg QD for 10 days | Drug | TBR-652 75 mg QD |
| TBR-652 100 mgTBR-652 100 mg QD for 10 days | Drug | TBR-652 100 mg QD |
| TBR-652 150 mgTBR-652 150 mg QD for 10 days | Drug | TBR-652 150 mg |
Primary outcome
HIV-1 RNA Change from Baseline
Time frame: 10 days
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 10 Jul 2013.
- Results publication: PubMed 21317794Lalezari J, Gathe J, Brinson C, Thompson M, Cohen C, Dejesus E, Galindez J, Ernst JA, Martin DE, Palleja SM. Safety, efficacy, and pharmacokinetics of TBR-652, a CCR5/CCR2 antagonist, in HIV-1-infected, treatment-experienced, CCR5 antagonist-naive subjects. J Acquir Immune Defic Syndr. 2011 Jun 1;57(2):118-25. doi: 10.1097/QAI.0b013e318213c2c0.
- Results publication: PubMed 21486960Marier JF, Trinh M, Pheng LH, Palleja SM, Martin DE. Pharmacokinetics and pharmacodynamics of TBR-652, a novel CCR5 antagonist, in HIV-1-infected, antiretroviral treatment-experienced, CCR5 antagonist-naive patients. Antimicrob Agents Chemother. 2011 Jun;55(6):2768-74. doi: 10.1128/AAC.00713-10. Epub 2011 Apr 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TBR-652, TBR-652 50 mg and TBR-652 75 mg in people with HIV-1 Infection, run by Tobira Therapeutics, Inc..
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 22 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 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 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?
HIV-1 RNA Change from Baseline (time frame: 10 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 NCT01092104, which also lists 2 linked publications.
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 10 Jul 2013.