NCT05896761

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Sub-study to the A2M Study to Evaluate the Pharmacokinetics, Tolerability and Efficacy of Cabotegravir and Rilpivirine Long-Acting Injections Following Intramuscular Administration in the Vastus Lateralis Muscle (Thigh) in HIV-infected Adult Participants Who Have Received at Least Three Years of Gluteal Injections in the A2M Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M \[A2M\]) study (NCT03299049).

Conditions

• Human Immunodeficiency Virus Type 1 (HIV-1)

Interventions

Type	Name	Description
DRUG	Cabotegravir Injectable Suspension	CAB LA injectable suspension is a sterile white to slightly pink suspension containing 200 milligrams per milliliter (mg/mL) of GSK1265744 as free acid for administration by IM injection. CAB LA injectable suspension is to be stored at up to 30 degree Celsius and should not be frozen.
DRUG	Rilpivirine Injectable Suspension	RPV LA injectable suspension is a sterile white suspension containing 300 mg/mL of RPV as the free base for administration by IM injection. RPV LA injectable suspension should be kept in the outer package and stored at 2-8 degree Celsius and should not be frozen. RPV LA should also be protected from light.

Timeline

• Start date: 2021-10-28
• Primary completion: 2022-08-23
• Completion: 2022-08-23
• First posted: 2023-06-09
• Last updated: 2023-09-18
• Results posted: 2023-09-18

Locations

32 sites across 7 countries: United States, Argentina, Canada, Germany, Italy, Spain, Sweden

Regulatory

• FDA-regulated drug study