HIV InfectionsPhase 2NCT00089700
TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1
A Phase 2 study testing TNX-355 in people with HIV Infections, run by Tanox at 15 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- TNX-355
- How many people
- 80 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Mar 2004to not given
- Phase
- Phase 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
- 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.
Who cannot join
- 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).
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- 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)
- Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing schedule and protocol evaluations
- Clinically significant laboratory findings obtained during screening including:
- Serum creatinine or BUN (>1.5 X Upper Limit of Normal [ULN])
- Alkaline phosphatase, aspartase aminotransferase (AST), alanine aminotransferase (ALT) (any > 2.5 [ULN])
- Total bilirubin (>1.5 ULN)
- Pancreatic amylase and/or lipase (>1.5 ULN)
- Hemoglobin (<9.0 g/dL for males; < 8.0 g/dL for females)
- Platelet Count (<75,000 x 106/L)
- Absolute Neutrophil Count (< 1,000 X 106/L)
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States13 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
Chase-Brexton Health Services, Inc.
Baltimore, Maryland, 21201
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Bach and Godofsky
Bradenton, Florida, 34205
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Tanox, Inc.
Houston, Texas, 77025
Altamed Corporation
Los Angeles, California, 90022
Tower ID Medical Associates
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33136
Brobson Lutz, MD, LLC
New Orleans, Louisiana, 70115
Body Positive
Phoenix, Arizona, 85006
Comprehensive Research Institute
Tampa, Florida, 33607
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
About this study
Official title: 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
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.
Read the detailed description
This 48-week, multicenter, randomized, double-blinded, placebo-controlled, multi-dose, three-arm safety and efficacy study of approximately 80 subjects will compare TNX-355 plus OBT to placebo plus OBT in adult subjects infected with HIV-1. Subjects must: 1) have a stable viral load of 10,000 copies/mL, determined within 8 weeks prior to randomization (Day 1); 2) have been treated with HAART for at least 6 months (cumulatively); 3) be triple class experienced, with historical evidence of exposure to each of the three traditional classes of antiretroviral therapy (ART): nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs); and 4) be presently failing or have failed a HAART regimen within 8 weeks prior to screening (Screening visit 1).
Subjects will be assigned to OBT based upon their past medication history and the results of the virus sensitivity testing (PSGT, ViroLogic, Inc.), and then randomized to a study arm to begin receiving OBT plus study medication at the Day 1 visit. Fusion/entry inhibitors will not be permitted as part of the optimized background therapy. All subjects will be randomized equally (1:1:1 ratio), in a double-blinded fashion, among three arms to receive OBT plus one of the following: Arm A, alternating intravenous infusions of TNX-355, 15 mg/kg and placebo weekly for the first 9 doses (through the Week 8 visit), and then intravenous infusions of TNX-355, 15 mg/kg every two weeks; Arm B, TNX-355, 10 mg/kg intravenous infusions weekly for the first 9 doses (through the Week 8 visit), and then intravenous infusions of TNX-355, 10 mg/kg every two weeks; or Arm C, weekly intravenous infusions of placebo for the first 9 doses (through the Week 8 visit), and then intravenous infusions of placebo every two weeks.
Subjects will continue to receive blinded therapy until that therapy fails. Subjects that do not achieve a viral load reduction of at least 0.5 log10 from their baseline value on two consecutive protocol-defined assessments after Week 12 will be considered virologic failures. Subjects that experience virologic failure after Week 16 (i.e., earliest point at which virologic failure can be confirmed after Week 12) will have the option of being assigned to new OBT plus open-label TNX-355 given as a 15 mg/kg infusion every two weeks. Subjects that experience a second virologic failure will be discontinued from the study. The total duration of study treatment will be 48 weeks, with the primary endpoint at Week 24.
- Conditions
- HIV Infections
- Being tested
- TNX-355
- Keywords
- HIV, AIDS, Treatment Experienced, Optimized Background Therapy, HIV-1
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-355Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2004 (estimated)
- Study startMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Tanox
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089700
- Sponsor's protocol ID
- TNX-355.03
- Status last verified
- Feb 2005
- First submitted
- 10 Aug 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 33427765
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00089700
- Acronym / sponsor ID
- TNX-355.03
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Treatment Experienced, Optimized Background Therapy, HIV-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- TanoxIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- First posted
- 12 Aug 2004 (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.
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.
Detailed description
This 48-week, multicenter, randomized, double-blinded, placebo-controlled, multi-dose, three-arm safety and efficacy study of approximately 80 subjects will compare TNX-355 plus OBT to placebo plus OBT in adult subjects infected with HIV-1. Subjects must: 1) have a stable viral load of 10,000 copies/mL, determined within 8 weeks prior to randomization (Day 1); 2) have been treated with HAART for at least 6 months (cumulatively); 3) be triple class experienced, with historical evidence of exposure to each of the three traditional classes of antiretroviral therapy (ART): nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs); and 4) be presently failing or have failed a HAART regimen within 8 weeks prior to screening (Screening visit 1).
Subjects will be assigned to OBT based upon their past medication history and the results of the virus sensitivity testing (PSGT, ViroLogic, Inc.), and then randomized to a study arm to begin receiving OBT plus study medication at the Day 1 visit. Fusion/entry inhibitors will not be permitted as part of the optimized background therapy. All subjects will be randomized equally (1:1:1 ratio), in a double-blinded fashion, among three arms to receive OBT plus one of the following: Arm A, alternating intravenous infusions of TNX-355, 15 mg/kg and placebo weekly for the first 9 doses (through the Week 8 visit), and then intravenous infusions of TNX-355, 15 mg/kg every two weeks; Arm B, TNX-355, 10 mg/kg intravenous infusions weekly for the first 9 doses (through the Week 8 visit), and then intravenous infusions of TNX-355, 10 mg/kg every two weeks; or Arm C, weekly intravenous infusions of placebo for the first 9 doses (through the Week 8 visit), and then intravenous infusions of placebo every two weeks.
Subjects will continue to receive blinded therapy until that therapy fails. Subjects that do not achieve a viral load reduction of at least 0.5 log10 from their baseline value on two consecutive protocol-defined assessments after Week 12 will be considered virologic failures. Subjects that experience virologic failure after Week 16 (i.e., earliest point at which virologic failure can be confirmed after Week 12) will have the option of being assigned to new OBT plus open-label TNX-355 given as a 15 mg/kg infusion every two weeks. Subjects that experience a second virologic failure will be discontinued from the study. The total duration of study treatment will be 48 weeks, with the primary endpoint at Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (24 listed)
- 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).
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 |
|---|---|---|
| TNX-355 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 33427765Gathe 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.
- Tanox, Inc. websiteLink 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNX-355 in people with HIV Infections, run by Tanox at 15 sites in 3 countries.
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 8 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada, Puerto Rico. 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 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00089700, 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 24 Jun 2005.