A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition
Overview
- Phase
- Phase 3
- Intervention
- CAB LA
- Conditions
- HIV Infections
- Sponsor
- ViiV Healthcare
- Enrollment
- 3508
- Locations
- 1
- Primary Endpoint
- Number of participants with new HIV infection
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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 consultation with the Medical Monitor.
- •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 current evidence) are immune to HBV and are not excluded.
- •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 abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator).
- •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 signing informed consent, unless permission from the Medical Monitor is granted.
- •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.
Arms & Interventions
CAB LA 600 mg (Q8W)
All enrolled participants have previously received CAB LA as part of the HPTN 083 and HPTN 084 parent studies or their sub-studies. Participants will continue receiving CAB LA 600 mg via gluteal intramuscular (IM) injection.
Intervention: CAB LA
Outcomes
Primary Outcomes
Number of participants with new HIV infection
Time Frame: From Day 1 up to end of study (up to approximately [approx.] 3 years)
Number of participants with new HIV infection by characteristic
Time Frame: From Day 1 up to end of study (up to approx. 3 years)
Relevant characteristics of new HIV infections will be assessed, including presence of viral resistance to CAB.
Secondary Outcomes
- Number of participants with serious adverse events (SAE) by severity(From Day 1 up to end of study (up to approx. 3 years))
- Number of participants with any clinical or laboratory AE leading to discontinuation of CAB LA, by severity(From Day 1 up to end of study (up to approx. 3 years))
- Number of participants with Grade 3 and Grade 4 injection site reactions (ISRs)(From Day 1 up to end of study (up to approx. 3 years))