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Antiretroviral Therapy
Cabotegravir + Rilpivirine for HIV During Pregnancy
Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the safety and effectiveness of long-acting injectable medications in pregnant women with HIV and their infants. The study will focus on how the medications are processed in the body and their
Who is the study for?
This trial is for pregnant individuals with HIV-1 who have managed to suppress the virus. It's open to those in any trimester and continues into the postpartum period. Participants must be on a stable antiretroviral regimen, with no plans to modify it except for participating in this study.
What is being tested?
The CREATE trial is testing two long-acting injectable drugs: Cabotegravir (CAB) at doses of either 400mg or 600mg, and Rilpivirine (RPV) at doses of either 900mg or 600mg. The goal is to see how these medications work and are processed by the body during pregnancy and after birth.
What are the potential side effects?
Possible side effects from CAB LA and RPV LA injections include pain at injection site, headache, fever, fatigue, muscle pains, sleep disturbances, rash, nausea. Long-term safety for both mother and infant will also be studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Q8W SwitchExperimental Treatment2 Interventions
Pregnant people between 10 0/7 and 19 4/7 weeks gestation with HIV-1 viral suppression on oral antiretroviral therapy willing to switch to an every eight week (Q8W) CAB LA + RPV LA regimen.
Group II: Q8W ContinuationExperimental Treatment2 Interventions
Pregnant people between 10 0/7 and 19 4/7 weeks gestation with HIV-1 viral suppression who were using every 8 week CAB LA + RPV LA at and since conception and are willing to continue their current CAB LA + RPV LA regimen.
Group III: Q4W SwitchExperimental Treatment4 Interventions
Pregnant people between 10 0/7 and 19 4/7 weeks gestation with HIV-1 viral suppression on oral antiretroviral therapy willing to switch to an every four week (Q4W) CAB LA + RPV LA regimen.
Group IV: Q4W ContinuationExperimental Treatment2 Interventions
Pregnant people 19 4/7 weeks gestation or less with HIV-1 viral suppression who were using every 4 week CAB LA + RPV LA at and since conception and are willing to continue their current CAB LA + RPV LA regimen.
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,392,789 Total Patients Enrolled