TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Three-Arm Study of the Anti-CD4 Monoclonal Antibody TNX-355 With Optimized Background Therapy in Treatment-Experienced Subjects Infected With HIV-1
1 other identifier
interventional
80
3 countries
15
Brief Summary
This is a 48-week study to compare TNX-355 plus OBT to placebo plus OBT in HIV subjects. You must have a stable viral load of at least 10,000 copies/ml, been treated with highly active antiretroviral therapy (HAART) for at least 6 months, be triple class experienced, and presently failing or have failed a HAART regimen. Subjects will receive infusions every week for 8 weeks, then every two weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 10, 2004
CompletedFirst Posted
Study publicly available on registry
August 12, 2004
CompletedJune 24, 2005
February 1, 2005
August 10, 2004
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have all of the following to be included in the study:
- Triple-class experience, with no minimum exposure to any class (historical exposure to NRTI, NNRTI, PI)
- Cumulative HAART experience for a minimum of 6 months
- Virus susceptibility to one or more antiretroviral drugs in their selected OBT as determined by the PhenoSenseGT or similar assay and medication history
- Stable plasma HIV-1 RNA levels quantitated by reverse-transcriptase polymerase chain reaction (RT-PCR) of 10,000 copies/mL within 8 weeks prior to randomization (Day 1), while receiving a stable HAART regimen for a minimum of 4 weeks prior to screening. Stable viral load is defined as a difference of 0.5-log10 in HIV-1 RNA copies/mL from two measurements obtained at least 48 hours apart during the screening period
- Subjects must be failing their current HAART regimen or have discontinued a failing HAART regimen within 8 weeks prior to screening (screening visit 1)
- CD4+ cell count 50 cells/mL
- If sexually active, willingness to use an effective, medically accepted (including barrier) method of contraception during the study. To prevent superinfection, any male subject and the male sexual partner of any study subject should use a condom. All study subjects and all of their sexual partners should practice additional safe sex techniques to prevent spread of HIV.
You may not qualify if:
- Subjects with any of the following characteristics will be excluded from the study:
- Any significant diseases (other than HIV infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination, determined from screening, that, in the investigator's opinion, would preclude the subject from participating in this study
- Acute illness within one week prior to administration of study drug (including diarrhea and/or vomiting and fever and/or other signs and symptoms of infection such as leukocytosis, etc.)
- Any active infection secondary to HIV, requiring acute therapy. However, subjects that require maintenance therapy (i.e. secondary prophylaxis for opportunistic infections) will be eligible for the study
- Any immunomodulating therapy or systemic chemotherapy within 12 weeks prior to randomization (Day 1)
- Any investigational drug use within 30 days prior to randomization (Day 1). This does not include investigational drugs for the treatment of HIV-1 (NRTI, NNRTI or PI) under expanded access. OBT may include drugs not currently approved, but prescribed under expanded access (limited to NRTI's, NNRTI's and PI's).
- Any prior participation in an HIV vaccine study
- Opportunistic infections (OIs) in the previous 12 weeks prior to randomization (Day 1)
- Any prior exposure to TNX-355 (Hu5A8)
- Vaccination within 21 days (3 weeks) prior to randomization (Day 1)
- Any previous exposure to any virus/fusion entry inhibitor/s
- Any previous exposure to a monoclonal antibody (prior treatment with hepatitis B immune globulin \[HBIG\] or intravenous immune globulin \[IVIG\] is acceptable)
- Life expectancy of less than 12 months
- Female subjects who are either pregnant or breastfeeding
- Any illicit intravenous drugs within 6 months prior to randomization (Day 1)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanoxlead
Study Sites (15)
Body Positive
Phoenix, Arizona, 85006, United States
Altamed Corporation
Los Angeles, California, 90022, United States
Tower ID Medical Associates
Los Angeles, California, 90048, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
University of Miami
Miami, Florida, 33136, United States
Comprehensive Research Institute
Tampa, Florida, 33607, United States
Brobson Lutz, MD, LLC
New Orleans, Louisiana, 70115, United States
Chase-Brexton Health Services, Inc.
Baltimore, Maryland, 21201, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Tanox, Inc.
Houston, Texas, 77025, United States
Sunnybrook Health Science Centre
Toronto, Ontario, M4N3M5, Canada
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
Related Publications (1)
Gathe JC, Hardwicke RL, Garcia F, Weinheimer S, Lewis ST, Cash RB. Efficacy, Pharmacokinetics, and Safety Over 48 Weeks With Ibalizumab-Based Therapy in Treatment-Experienced Adults Infected With HIV-1: A Phase 2a Study. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):482-489. doi: 10.1097/QAI.0000000000002591.
PMID: 33427765DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 10, 2004
First Posted
August 12, 2004
Study Start
March 1, 2004
Last Updated
June 24, 2005
Record last verified: 2005-02