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CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

NCT06336434 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-07-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

CAB LA 600mg

600mg (3mL) IM Injection

DRUG

RPV LA 900mg

900mg (3mL) IM Injection

DRUG

CAB LA 400mg

400mg (2mL) IM Injection

DRUG

RPV LA 600mg

600mg (2mL) IM injection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2028-01-30
Completion
2028-01-30
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06336434 on ClinicalTrials.gov