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Integrase Inhibitor, Non-Nucleoside Reverse Transcriptase Inhibitor

Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

Phase 2

Waitlist Available

Research Sponsored by ViiV Healthcare

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 up to end of maintenance phase (up to month 52 for cab la+rpv la q2m group, up to month 12 for dtg+rpv group)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of long-acting injections given periodically to adults with HIV-1 who have already managed the virus with daily pills. The goal is to maintain virus suppression without daily medication. Long-acting injectable cabotegravir and rilpivirine have shown similar results to daily oral treatments in previous studies.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV Suppression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to end of maintenance phase (up to month 52 for cab la+rpv la q2m group, up to month 12 for dtg+rpv group)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to end of maintenance phase (up to month 52 for cab la+rpv la q2m group, up to month 12 for dtg+rpv group)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of maintenance phase (up to month 52 for cab la+rpv la q2m group, up to month 12 for dtg+rpv group) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase]

Secondary study objectives

Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase]

Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase

+58 more

Other study objectives

Ctrough for RPV LA

Plasma Trough Concentration (Ctrough) for CAB LA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: LTFU: CAB LA+RPV LA Q2M GroupExperimental Treatment2 Interventions

This group included the participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason before end of Maintenance Period. The participants entered a 52-week LTFU period.

Group II: DTG + RPVExperimental Treatment2 Interventions

Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase.

Group III: CAB LA + RPV LA Q2MExperimental Treatment2 Interventions

Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CAB LA

2014

Completed Phase 3

~1090

RPV LA

2018

Completed Phase 3

~660