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TNX-355 for HIV

Phase 2

Waitlist Available

Research Sponsored by Tanox

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Virus susceptibility to one or more antiretroviral drugs in their selected OBT as determined by the PhenoSenseGT or similar assay and medication history

Subjects must be failing their current HAART regimen or have discontinued a failing HAART regimen within 8 weeks prior to screening (screening visit 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new drug, TNX-355, to see if it is better than the current best treatment for HIV.

Who is the study for?

This trial is for adults with HIV-1 who have been on highly active antiretroviral therapy (HAART) for at least 6 months, are experienced with three classes of HIV medications, and currently have a viral load over 10,000 copies/ml. Participants must not be responding well to their current HAART regimen. They should also agree to safe sex practices and contraception during the study.Check my eligibility

What is being tested?

The study tests TNX-355 given through infusions alongside optimized background therapy (OBT), compared to a placebo plus OBT in subjects with treatment-experienced HIV-1. The trial lasts for 48 weeks, with initial weekly infusions followed by bi-weekly treatments.See study design

What are the potential side effects?

While specific side effects of TNX-355 aren't listed here, similar drugs can cause infusion reactions, immune system changes leading to infections or autoimmune disorders, allergic responses, and potential interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My virus responds to at least one drug in my treatment plan, confirmed by a specific test.

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My current HIV treatment is not working or I stopped a failing HIV treatment within the last 8 weeks.

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I have been on HIV treatment for at least 6 months.

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My HIV is stable with a viral load under 10,000 copies/mL and I've been on consistent treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

TanoxLead Sponsor

6 Previous Clinical Trials

973 Total Patients Enrolled

Media Library

Optimized Background Therapy (OBT) Clinical Trial Eligibility Overview. Trial Name: NCT00089700 — Phase 2

Human Immunodeficiency Virus Infection Research Study Groups:

Human Immunodeficiency Virus Infection Clinical Trial 2023: Optimized Background Therapy (OBT) Highlights & Side Effects. Trial Name: NCT00089700 — Phase 2

Optimized Background Therapy (OBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00089700 — Phase 2

Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT00089700 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this medication been okayed by the FDA?

"This Phase 2 treatment option does not have any solid clinical data supporting its efficacy, but there is some evidence that it is safe."

Answered by AI

Are new participants still being enrolled in this clinical trial?

"The listed clinical trial on clinicaltrials.gov is not presently recruiting patients, as it was last edited on 6/23/2005. Although this specific study isn't looking for volunteers at the moment, there are 499 other trials that are currently open for recruitment."

Answered by AI

Are seniors welcome to participate in this clinical trial?

"According to the age guidelines set out in the inclusion criteria, patients must be between 18 and 0 years old to participate."

Answered by AI

If a patient wants to participate in this trial, will they have to travel out of state?

"Currently, patients can enroll in this trial at Brobson Lutz, MD, LLC located in New Orleans, Louisiana; University of Cincinnati Medical Center situated in Cincinnati, Ohio; and Johns Hopkins University School of Medicine based in Baltimore, Maryland. There are a total of 14 sites where patients can participate."

Answered by AI