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Antiretroviral Therapy

Q4W Switch for HIV

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 through 18 weeks postpartum

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ through 18 weeks post-birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 18 weeks post-birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 18 weeks post-birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PK trough of CAB LA measured in plasma in pregnancy and postpartum

Percentage of adults with at least one Grade 3 or higher adverse event in pregnancy and through 18 weeks postpartum

Percentage of adults with at least one serious adverse event in pregnancy and through 18 weeks postpartum

Secondary outcome measures

CAB and RPV plasma concentrations in infants exposed to CAB LA + RPV LA during pregnancy and via chest/breastfeeding

Frequency of CAB LA + RPV LA injections received

Number of adults with HIV-1 resistance to CAB and/or RPV using IAS-USA in participants who experience confirmed virologic failure, assessed at entry and time of failure

+19 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,192 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase for this medical study currently ongoing?

"As per the details on clinicaltrials.gov, recruitment for this specific trial is currently closed. It was first listed on 9/24/2024 and last updated on 3/21/2024. However, it's worth noting that while this study is not actively enrolling participants, there are approximately 180 other trials seeking candidates at present."

Answered by AI

In how many medical facilities is this examination being conducted?

"There are currently 8 available slots for new participants in this research project, with enrolment sites like Site 5048 at the University of Southern California LA in Los Angeles, Site 8052 based in Soweto within Johannesburg, and Site 8950 at FAMCRU CRS located in Parow. Additional opportunities exist across a further eight venues."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

2024. "CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336434.