Investigator-Sponsored Protocol - Continued Use of Ibalizumab
This study is ongoing, but not recruiting participants.
Sponsor:
Kaiser Permanente
Collaborator:
TaiMed Biologics Inc.
Information provided by (Responsible Party):
William J. Towner, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01056393
First received: January 22, 2010
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1 (Amended to 24 Week Study)"), for 24 weeks. Ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: ibalizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Investigator-Sponsored Protocol - Continued Use of Ibalizumab |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Kaiser Permanente:
Primary Outcome Measures:
- Laboratory testing that includes routine HIV-1 viral load and CD4+ cell counts will be completed to assess the continued benefit of ibalizumab to the patient's HIV treatment. [ Time Frame: Every two months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 4 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 800mg Q2Weeks
Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen
|
Drug: ibalizumab
Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 800mg q2weeks, or 2000mg q4weeks.
Other Names:
|
|
Experimental: 2000mg Q4Weeks
Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen
|
Drug: ibalizumab
Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 800mg q2weeks, or 2000mg q4weeks.
Other Names:
|
Detailed Description:
Ibalizumab is to be administered to HIV-infected patients that have responded (defined as a minimum 0.7 log10 decline in HIV-1 viral load from TMB-202 Baseline) on the TMB-202 protocol. In addition to the investigator-selected Optimized Background Regimen, patient(s) will continue to receive the TMB-202 randomized dose of ibalizumab in open-labeled fashion (800mg IV every two weeks or 2000mg IV every four weeks) as per their original drug assignment for the TMB-202 protocol.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Capable of understanding and have voluntarily signed the ICF
- Have documented HIV-1 infection
- Have successfully completed Protocol TMB202 (Amendment 2)(Week 16)
- Have had at least a 0.7 log10 decline in HIV-1 RNA from baseline at Week 16 and beyond while in TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure
- Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason
- Are able and willing to comply with all protocol requirements and procedures
- Are 18 years of age or older
- If sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug.
Exclusion Criteria:
- Any active AIDS-defining illness per Category C except for cutaneous Kaposi's sarcoma and wasting due to HIV
- Any significant disease (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
- Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations
- Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056393
Locations
| United States, California | |
| Kaiser Permanente Southern California | |
| Los Angeles, California, United States, 90027 | |
Sponsors and Collaborators
Kaiser Permanente
TaiMed Biologics Inc.
Investigators
| Principal Investigator: | William Towner, MD | Kaiser Permanente |
More Information
No publications provided
| Responsible Party: | William J. Towner, Partner Physician, Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT01056393 History of Changes |
| Other Study ID Numbers: | 5460 |
| Study First Received: | January 22, 2010 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Kaiser Permanente:
|
HIV |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013