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Long-Acting Cabotegravir + rHuPH20 for HIV Infection
Study Summary
This trial is testing two different doses of a new medication to see how safe and well-tolerated it is, as well as how it is metabolized by the body.
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.Side effects data
From 2009 Phase 2 trial • 22 Patients • NCT00774800Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I have had COVID-19 symptoms or contact with a COVID-19 positive person in the last 14 days.My hemoglobin level is below the normal range for my gender.I have had a heart attack before.My kidney function is reduced, with an eGFR below 60 mL/min.I do not have any heart rhythm problems that could make the trial unsafe for me.I haven't had seizures or needed treatment for them in the last 2 years.I have a history of liver disease or known liver problems.I have not been exposed to more than four new drugs in the last year.I have or had heart, lung, liver, kidney, stomach, hormone, blood, or nerve disorders.I am between 18 and 55 years old.I weigh at least 40 kg and my BMI is between 18 and 32.My blood pressure is not normal.You are negative on two (2) consecutive tests for SARS-CoV-2, one performed prior to admission to the Phase 1 unit (up to Day 7 prior to admission) and one prior to dosing, i.e.I need or will need long-term blood thinners.I have a genetic blood clotting disorder like hemophilia or VWD.I have a skin condition or tattoo that could affect the study's injection site.
- Group 1: Part A: Participants receiving CAB 200 mg/mL with rHuPH20
- Group 2: Part C: Participants receiving CAB 400 mg/mL
- Group 3: Part D: Participants receiving CAB 400 mg/mL with rHuPH20
- 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
Are there any dangers associated with Recombinant human hyaluronidase PH20 (rHuPH20)?
"Because this is a Phase 1 trial, there is only limited data supporting the safety and efficacy of Recombinant human hyaluronidase PH20 (rHuPH20), so our team at Power gave it a score of 1."
Who would be the best candidate for this research?
"This clinical trial is for 60 participants who are HIV positive and between the ages of 18 and 55. The following additional criteria must be met: participants must be healthy as determined by medical evaluation, have a body weight of at least 40 kg and a BMI within the range of 18-32 kg/m^2, be using contraception consistently, be able to give written informed consent, and have two negative tests for SARS-CoV-2 prior to admission to the Phase 1 unit and prior to dosing."
Are participants in this clinical trial restricted to a certain age range?
"This study's parameters for inclusion state that only patients aged 18 to 55 may enroll. However, there are 109 other clinical trials available for minors and 364 for elderly patients."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
How responsive is this trial?
Most responsive sites:
- GSK Investigational Site: < 48 hours
Average response time
- < 2 Days
Typically responds via
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