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Long-Acting HIV Drugs for HIV
Study Summary
This trial will test a new, long-acting drug combination to treat HIV-1 in adults with suppressed plasma viremia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am 18 years old or older.It is okay if you have switched medication before for reasons other than the medication not working.My HIV viral load was once between 50-200 copies/mL but is now under 50 copies/mL.My condition is responsive to VRC07-523LS treatment.I do not have any illness that would stop me from attending study visits.The study requires the use of a specific kit that has been approved by the US FDA.I have not had an AIDS-defining illness in the last 60 days.If you test positive for HIV, a different type of test will be used to confirm the result. This is required by WHO and CDC guidelines to ensure accuracy.You must have had a negative HIV test within the past 2 years, with no detectable levels of the virus.My weight is either over 115 kg or under 53 kg.My CD4+ T-cell count is 350 or higher.I or someone in my family has a history of prolonged QT syndrome.You had a serious allergic reaction within the last 2 years before joining the study.I agree to use effective birth control.I am a woman who can have children and have a negative pregnancy test taken within the last 48 hours.I haven't used immunomodulators, chemotherapy, or experimental drugs in the last 60 days.My liver condition is stable and I have no known biliary abnormalities.I can have needles inserted into my arm veins without issue.I am willing and able to continue my current two NRTIs treatment.I have a confirmed HIV-1 infection.I've been stable on my current HIV treatment for at least 8 weeks without changing it due to failure.My recent CD4+ T-cell count is 350 or higher.I have not had seizures or treatment for seizures in the last 2 years.I have received a human or humanized monoclonal antibody treatment before.I haven't been hospitalized or seriously ill in the last 30 days.My liver function is significantly impaired.I started HIV treatment early after diagnosis.I have been treated for hepatitis C within the last 6 months.You have had multiple tests for HIV-1 RNA and all results have shown less than 50 copies/mL within the past year.I have been stable on a three-drug HIV treatment for at least 8 weeks.I meet the initial requirements to participate.
- Group 1: CAB LA + VRC07-523LS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has this research been done before?
"Since 2014, Standard of Care (SOC) Oral ART has undergone extensive research with the first study being sponsored by Janssen Pharmaceuticals. In total, there have been 16 active trials spanning 155 cities and 30 countries. As a result of the initial trial in 2014 involving 309 patients, this medication received Phase 2 drug approval."
Are there any other ongoing research projects that compare different treatments for HIV patients?
"Standard of Care (SOC) Oral ART was first studied in 2014 at GSK Investigational Site. So far, there have been 27 completed clinical trials. Presently, 16 live clinical trials are underway; many of these taking place in New york City."
How many people are signing up for this clinical trial?
"This study has closed recruitment and is not currently looking for any more participants. The clinical trial was first posted on December 31st, 2019 and updated for the last time on November 10th, 2022. There are 499 other trials concerning HIV infection and 16 Standard of Care Oral ART trials that are still recruiting patients."
Is the Standard of Care Oral ART treatment plan approved by the FDA?
"Standard of Care (SOC) Oral ART has only been proven safe in clinical trials, not effective. Our team rated it a 2."
What do medical professionals usually prescribe Standard of Care (SOC) Oral ART for?
"The Standard of Care (SOC) Oral ART is a common treatment for hiv test negative. This course of care can also be used to effectively treat weight at least 35 kg, treatment failure, and virologically-supressed patients."
In how many different locations is this trial being conducted?
"Currently, there are 19 sites running this study. They are based in New york, Birmingham and Aurora as well as other cities 19 other locations. If you enroll in the study, try to select the location nearest you to reduce travel time commitments."
Can patients join in this research right now?
"According to the latest update on clinicaltrials.gov, this trial is not currently looking for participants. Although 515 other trials are still recruiting patients, this particular study has not been since November 10th, 2020."
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