CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: HIV-1-infection, Pregnancy, Postpartum

In brief

This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

Key facts

Study ID

NCT06336434

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Starts

2025-05-01

Expected to finish

2028-01-30

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent for study participation for self and infant.
• Note: All sites must follow all applicable IRB/EC policies and procedures; for US sites, this includes single IRB (sIRB) policies and procedures.
• At screening, age 18 years or older.
• At entry, evidence of a viable, intrauterine, singleton pregnancy with fetal ultrasound performed per protocol and within the following estimated gestational age (EGA) ranges per protocol:
• Switch Group: EGA between 10 0/7 and 19 4/7 weeks (inclusive) at entry.
• Continuation Group: EGA less than or equal to 19 4/7 weeks at entry.
• Note: If adequate ultrasound results are not available from medical records at screening per protocol, an ultrasound must be performed prior to study entry.
• At entry, intending to deliver at a study-associated medical facility, remain in the geographic area of the study for the duration of anticipated follow-up, and attend regularly scheduled study visits.
• Confirmed HIV-1 infection based on documented testing of two samples collected from two separate blood collection tubes per Sample #1 and Sample #2 requirements. Test results may be obtained from medical records or from testing performed at screening (i.e., from specimens collected within 28 days prior to entry):
• For results obtained from medical records, adequate source documentation, including the date of specimen collection, date of testing or date of test result, name of test/assay performed, and test result, must be available in study records prior to study entry. Requirements related to laboratory operations (e.g., Good Clinical Laboratory Practice [GCLP], Clinical Laboratory Improvement Amendments [CLIA], Virology Quality Assurance [VQA]) and related to regulatory authority approvals (e.g., FDA) do not apply to results obtained from medical records.
• If adequate source documentation is not available, Sample #1 and/or Sample #2 should be collected during the study screening period and tested in the site's designated testing laboratory.
• If both samples are tested using antibody tests, at least one of the samples must be tested in a laboratory that operates according to CLIA or equivalent (for US sites) or GCLP (for South African sites) guidelines and participates in an appropriate external quality assurance program. If nucleic acid testing (NAT) is used, at least one test must be performed in the site's CLIA-certified or equivalent (for US sites) or VQA-certified (for South African sites) laboratory.
• Sample #1 may be tested using any of the following:
• Two rapid antibody-based tests from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used)
• One enzyme immunoassay (EIA) or Western blot (WB) or immunofluorescence assay or chemiluminescence assay
• One HIV-1 DNA polymerase chain reaction (PCR)
• One quantitative HIV-1 RNA PCR (above the limit of detection of the assay)
• One qualitative HIV-1 RNA PCR
• One HIV-1 total NAT
• Sample #2 may be tested using any of the following:
• Rapid antibody-based test. If this option is used in combination with two rapid tests for Sample
• #1, at least one of the three rapid tests must be FDA-approved and the third rapid test must be from a third manufacturer or based on a third principle or epitope. Combination antigen-antibody based rapid tests may be used.
• One EIA or WB or immunofluorescence assay or chemiluminescence assay
• One HIV-1 DNA PCR
• One quantitative HIV-1 RNA PCR (above the limit of detection of the assay)

You may not qualify if…

• Within nine months (270 days) prior to entry, any plasma HIV-1 RNA measurement greater than or equal to 200 copies/mL or two or more detectable plasma HIV-1 RNA measurements greater than or equal to 50 copies/mL at least 14 days apart.
• History of treatment/virologic failure associated with documented or presumed viral resistance to NNRTI or INSTI, defined as two consecutive plasma HIV-1 RNA measurements greater than or equal to 200 copies/mL after initial suppression to less than 50 copies/mL.
• Has any of the following, as determined by the site investigator based on participant report, clinical evidence, and/or available antenatal/medical care records:
• Historical or suspected resistance to NNRTI and INSTI classes, (i.e., presence of NNRTI and/or INSTI resistance associated substitutions or a phenotype resistance result to any NNRTI and/ or INSTI).
• Note: If there are questions regarding suspected resistance, the site investigator should consult with the CMC prior to enrolling the participant.
• HIV-1 Subtype A6
• Hypersensitivity reaction (HSR), known or suspected allergy to study product components, or any other contraindication to CAB or RPV.
• Contraindication to IM injection such as a current inflammatory skin condition that compromises the safety of IM injections or a dermatological condition which, may interfere with the interpretation of ISRs (including but not limited to gluteal implants).
• Note: Use of the proper needle length based on participant body size and shape is essential to ensure correct IM injection technique. See protocol for more information. High body mass index (BMI) is not considered exclusionary.
• Known ARV treatment interruption (greater than 30 consecutive days) in the 24 months prior to entry.
• For participants on EFV, known treatment interruption (greater than seven consecutive days) in the 24 months prior to entry.
• Any use of Nevirapine (ever), including, but not limited to a short course regimen to prevent perinatal transmission.
• At entry, current use or anticipated need of therapeutic anticoagulation (e.g., low molecular weight heparin, coumadin, heparin, or enoxaparin).
• History of known or suspected bleeding disorder.
• Current severe hepatic impairment (Class C) as determined by Child-Pugh classification.
• Suicidal ideation or attempt within six months of entry, based on completion of the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Unstable or poorly controlled seizure disorder.
• Known tuberculosis infection.
• Ongoing malignancy other than Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia.
• Symptoms suggestive of active coronavirus disease 2019 (COVID-19) or test results or contacts that require isolation or quarantine per local clinical practice, public health, and/or infection control guidelines.
• Note: Potential participants with symptoms suggestive of active COVID-19, test results, and/or contacts that require quarantine may resume screening (or be re-screened) after symptoms have resolved and applicable quarantine requirements have been completed.
• Known to have any of the following during the current pregnancy as determined by the site investigator based upon participant report, clinical evidence, and/or available antenatal/medical care records:
• Multiple gestation
• Abnormal placentation, including placenta previa (complete) and placenta accreta/increta/percreta
• Cervical cerclage/cervical incompetence

Where it is running

• Site 4601, University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program — La Jolla, California, United States
• Site 5048, University of Southern California LA — Los Angeles, California, United States
• Site 5092, Johns Hopkins University, Baltimore — Baltimore, Maryland, United States
• Site 5013, Jacobi Medical Center Bronx — The Bronx, New York, United States
• Site 8051 - Wits RHI Shandukani Research Centre — Johannesburg, South Africa
• Site 8052, Soweto — Johannesburg, South Africa
• Site 8950, FAMCRU CRS — Parow, South Africa
• Site 30300, Umlazi Clinical Research Site — Umlazi, South Africa

Full record on ClinicalTrials.gov

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