BridgeMD
New treatment option for HIV Infections
Official title Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
ClinicalTrials.gov ID: NCT06134362
What this study is testing
What is CAB LA?
CAB LA is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hiv infections.
Also referred to as Apretude, CAB LA for PrEP.
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
- The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
- 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
Adults. Healthy volunteers may be eligible.
You may be able to join if
- Type of participant
- Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm:
- HPTN 083 open label extension
- HPTN 084 open label extension (including pregnancy sub-study) Participants that completed study participation ≥3 months ago must be discussed with...
- Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
You likely can't join if
- Concurrent conditions/medical history (includes liver function)
- Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving...
- Previous premature discontinuation from IP in the parent study/sub-study.
- ALT \>5 × ULN; or ALT\>3 × ULN and bilirubin \>1.5 × ULN (with \>35% direct bilirubin) in the screening liver chemistry test result.
- Participants with known active hepatitis B infection (as indicated by a positive HBsAg and/or quantifiable HBV DNA). Participants negative for HBsAg...
- Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric...
See the full eligibility criteria
- Type of participant
- Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm:
- HPTN 083 open label extension
- HPTN 084 open label extension (including pregnancy sub-study) Participants that completed study participation ≥3 months ago must be discussed with the Medical Monitor prior to enrolment. Participants who have...
- Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
- Participants must have nonreactive HIV tests at Screening (rapid test, immunoassay [antigen/antibody] test and HIV-1 RNA results must all be available and nonreactive) and Day 1 (at least one of rapid test and...
- Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk...
- Participant or caregiver/legal guardian is able and willing to provide signed informed consent as described in Protocol Section 11.1.5, which includes compliance with the requirements and restrictions listed in the...
- Concurrent conditions/medical history (includes liver function)
- Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following...
- Previous premature discontinuation from IP in the parent study/sub-study.
- ALT \>5 × ULN; or ALT\>3 × ULN and bilirubin \>1.5 × ULN (with \>35% direct bilirubin) in the screening liver chemistry test result.
- Participants with known active hepatitis B infection (as indicated by a positive HBsAg and/or quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and/or...
- Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary...
- Known history of cirrhosis with or without viral hepatitis co-infection.
- Participant is currently participating in or has participated in a study (other than the studies listed in Inclusion Criteria 1) with a compound or device that is not commercially available within 30 days prior to...
- Presence of or any history of allergy/sensitivity to the study drug or its components.
- Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. Mild skin conditions may not be exclusionary at the discretion of the investigator or designee.
- Participant has a gluteal implant, tattoo or other dermatological condition overlying the buttock region which in the opinion of the investigator or designee may interfere with the injection or interpretation of ISRs.
- Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. Concomitant medications
- Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication.
- Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug: drug interactions with study treatment throughout the entire study period. Relevant habits
- Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Any condition (i(including but not limited to substance use disorder) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet...
- Participant has in the last 14 days prior to screening presented with signs and symptoms, which, in the opinion of the investigator, are suggestive of acute HIV infection. Participants may only be enrolled if clinical...
- Participant is a ward of the state (e.g. child in care).
The study team makes the final eligibility decision.
Where it's taking place
- Almagro, Argentina
- Buenos Aires, Argentina
- Francistown, Botswana
- Porto Alegre, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Mbabane, Eswatini
- Kisumu, Kenya
- Blantyre, Malawi
- Lilongwe, Malawi
- Lima, Peru
- Piura, Peru
- Cape Town, South Africa
- City of Cape Town, South Africa
- City of Johannesburg, South Africa
- Durban, South Africa
- Isipingo, South Africa
- Sol Plaatjie, South Africa
- Chiang Mai, Chiang Mai, Thailand
- Pathum Wan, Thailand
+ 4 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, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almagro, Argentina; Buenos Aires, Argentina; Francistown, Botswana; Porto Alegre, Brazil; Rio de Janeiro, Brazil; São Paulo, Brazil and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.