Is NCT05418868 recruiting in Austin, TX?

Yes, NCT05418868 is currently recruiting participants at its Austin, TX location. This hiv infections clinical trial is actively enrolling qualified participants.

How do I join the hiv infections clinical trial in Austin?

To join this clinical trial in Austin, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Austin clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV Infections Clinical Trial in Austin, TX

About This HIV Infections Study in Austin

This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.

Sponsor: ViiV Healthcare

Who Can Participate

Inclusion Criteria

At the time of obtaining informed consent, participants age should be greater than or equal to (\>=)18 years and less than or equal to (\<=) 55 years.

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Body weight \>=40 kilogram (kg) and body mass index (BMI) within the range \>=18 to \<=32 kilogram per meter square (kg/m\^2).

Participants who are negative on a single test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction \[PCR\] laboratory or point of care test), performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Capable of giving written informed consent.

Exclusion Criteria

Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.

Current or chronic history of liver disease or known hepatic or biliary abnormalities.

History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.

Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of coronavirus disease 2019 (COVID-19) (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.

Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.

History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.

Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.

Abnormal blood pressure.

Evidence of previous myocardial infarction.

Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular \[AV\] block \[2nd degree or higher\], Wolff- Parkinson-White \[WPW\] syndrome).

Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant.

One or more exclusionary values for a screening Electrocardiogram (ECG).

Alanine transaminase (ALT) \>1.5x upper limit of normal (ULN).

Bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]).

Estimated Glomerular Filtration Rate (eGFR) \<60 milliliter per minute (mL/min) using the Chronic Kidney Disease

Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021).

Hemoglobin \<12.5 gram per deciliter (g/dL) for men and \<11 g/dL for women.

Positive pre-study drug/alcohol screen.

Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices).

Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of \>14 units for males or \>7 units for females.

Regular use of known drugs of abuse.

Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.

Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day.

History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation, including a known hypersensitivity to hyaluronidases.

Current or anticipated need for chronic anti-coagulation therapy.

Hereditary coagulation and platelet disorders (e.g., hemophilia or Von Willebrand disease \[VWD\]).

Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention.

Any other clinical condition, behavior or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.

Participant who in the investigator's judgment poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Austin?

Yes, this clinical trial (NCT05418868) has an active research site in Austin, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV Infections Treatment Options in Austin, TX

If you're searching for hiv infections treatment options in Austin, TX, this clinical trial (NCT05418868) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Austin research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hiv infections specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv infections clinical trials near you to find additional studies recruiting in your area.

HIV Infections Clinical Trial in Austin, TX

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