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Tests treatment safety and results for HIV Infections
Official title A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
ClinicalTrials.gov ID: NCT06694805
What this study is testing
What is CAB LA + RPV LA?
CAB LA + RPV LA is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Age 1\. Aged \>=12 years and \>=35 kg (at the time of obtaining informed consent).
- Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence...
- Pregnancy, Sex and Contraceptive/Barrier Requirements 5. Person of childbearing potential (POCBP) must have a negative serum or urine pregnancy test...
- Informed Consent/Assent 6.Informed consent/Assent must be provided as follows:
- Adult participants (\>=18 years old) must be capable of giving signed informed consent as described in the full study protocol, which includes...
You likely can't join if
- Medical Conditions
- HIV-1 Subtype A6, if known from historical result.
- Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or...
- Individuals with both HIV and Hepatitis B virus (HBV) will be excluded from participating in studies where they would not be able to receive...
- History of liver cirrhosis with or without hepatitis viral co-infection.
See the full eligibility criteria
Who can join
- Age 1\. Aged \>=12 years and \>=35 kg (at the time of obtaining informed consent).
- Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed...
- Pregnancy, Sex and Contraceptive/Barrier Requirements 5. Person of childbearing potential (POCBP) must have a negative serum or urine pregnancy test at screening and on Day 1.
- Informed Consent/Assent 6.Informed consent/Assent must be provided as follows:
- Adult participants (\>=18 years old) must be capable of giving signed informed consent as described in the full study protocol, which includes compliance with the requirements and restrictions listed in the informed...
- For adolescent participants (12 to \<18 years of age at screening), the parent(s) or legal guardian must be capable of giving signed informed consent.
What rules you out
- Medical Conditions
- HIV-1 Subtype A6, if known from historical result.
- Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the...
- Individuals with both HIV and Hepatitis B virus (HBV) will be excluded from participating in studies where they would not be able to receive appropriate therapy for their HBV co-infection and therefore may be at risk of...
- History of liver cirrhosis with or without hepatitis viral co-infection.
- Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
- Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).
- Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.
- History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates...
- Participants who in the investigator's judgment, pose a significant suicidality risk. Participant's history of suicidal behaviour and/or suicidal ideation should be considered when evaluating for suicide risk.
- Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may...
- Prior/Concomitant Therapy
- Any previous use of CAB.
- Current or anticipated need for chronic anti-coagulants.
- Use of concomitant medications which are associated with Torsades de Pointes (TdP).
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
- Treatment with any of the following agents within 28 days of Screening:
- radiation therapy;
- cytotoxic chemotherapeutic agents;
- tuberculosis therapy with the exception of isoniazid;
- anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (\<=325mg);
- immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first...
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- Prior/Concurrent Clinical Study Experience
- Participant is currently participating in, or anticipates being selected for, any other treatment study.
- Diagnostic assessments
- Any evidence of viral drug resistance based on the presence of any major RAM to INSTIs or NNRTIs in the Screening result; or, if known, in any historical resistance test result.
- Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
- Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.
- ALT \>=5 times ULN or ALT \>=3×ULN and bilirubin \>=1.5×ULN (with \>35% direct bilirubin).
- eGFR of \<30 mL/min/1.73 m2 via refitted, race-neutral CKD-EPIcr\_R method (adult participants) or \<50 mL/min/1.73 m2 using the Bedside Schwartz equation (adolescent participants).
- Hemoglobin \<9.0 g/dL.
- Corrected QT interval (QTc \>450 msec or QTc \>480 msec for participants with bundle branch block, calculated using ECGs performed in triplicate).
- Other exclusions
- Unwilling to receive injections, or unable to receive gluteal injections.
- The participant has gluteal implants or prosthesis; or a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reaction (ISRs).
- Evidence of alcohol or substance use disorder within the previous 12 months, using standard methods for their site, that would interfere with the participant's safety.
- Adolescents who are wards of the state or government. To assess any potential impact on participant eligibility with regard to safety, the investigator must refer to the Investigator's brochure (IB) and supplements...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Sarasota, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Macon, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Berkley, Michigan, United States
- Kansas City, Missouri, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Beverly Hills, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Denver, Colorado, United States; New Haven, Connecticut, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.