HIV -1 Infection study: Every
Official title Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
ClinicalTrials.gov ID: NCT07637942
What this study is testing
What is Long-acting injectable cabotegravir and rilpivirine?
An investigational once-monthly injectable medicine being studied for HIV-1 infection during pregnancy and postpartum is designed to inhibit HIV replication by blocking viral integrase and reverse transcriptase
Also referred to as cabotegravir and rilpivirine.
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 study looks at how the drugs cabotegravir and rilpivirine behave in the body of pregnant people and in the weeks after delivery.
- Who it's for
- Pregnant people living with HIV who are willing to receive the injectable treatment.
- What's involved
- Participants receive the long‑acting injections and have blood tests and visits to monitor drug levels and health.
- Time commitment
- The study lasts through pregnancy and the postpartum period, with regular clinic visits for injections and blood sampling.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Willing and able to provide written informed consent for study participation for self and infant
- At screening, age 18 years or older
- Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks...
- At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated...
- Was diagnosed with HIV prior to the current pregnancy
You likely can't join if
- History of treatment/virologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)
- Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any...
- Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta...
- Had any of the following in a previous pregnancy: (1) Eclampsia/Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome
- Receipt of any prohibited medication within seven days prior to entry
- Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV
See the full eligibility criteria
- Willing and able to provide written informed consent for study participation for self and infant
- At screening, age 18 years or older
- Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks (inclusive) at entry
- At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up
- Was diagnosed with HIV prior to the current pregnancy
- Has a documented plasma HIV RNA result less than 50 copies/mL from a specimen collected within 28 days prior to entry
- Has the following laboratory test results from a specimen collected within 28 days prior to entry (1) Grade 2 or lower platelets (greater than or equal to 50,000 cells/mm3 or greater than or equal to 50.00 x 109...
- Received first dose of CAB LA + RPV LA prior to entry (before or after conception of the current pregnancy) and is expected to receive CAB LA + RPV LA on a Q4W schedule for the duration of study participation
- History of treatment/virologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)
- Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any other contraindication to CAB or RPV
- Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta/increta/percreta; (2) Cervical cerclage/cervical incompetence
- Had any of the following in a previous pregnancy: (1) Eclampsia/Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome
- Receipt of any prohibited medication within seven days prior to entry
- Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV
- Receipt of an investigational agent or chemotherapy within 30 days prior to study entry
- Adult-participant or fetus has any condition, such as uncontrolled diabetes, hypertension, or other comorbidities, that, in the opinion of the site investigator, would make participation in the study unsafe, complicate...
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
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, but 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Chicago, Illinois, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.