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Nucleoside Reverse Transcriptase Inhibitor

RPV for Human Immunodeficiency Virus Infection

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 pre-dose and 2 hours post dose on day 1, pre-dose on weeks 1,4,8,12,16,20,24,25,28 and 32

Awards & highlights

Study Summary

This trial is testing an injectable drug combination to see if it is more effective, safe, and tolerable than an oral drug combination in HIV-1 infected people who have not taken antiretroviral drugs before.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV/AIDS

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and 2 hours post dose on day 1, pre-dose on weeks 1,4,8,12,16,20,24,25,28 and 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and 2 hours post dose on day 1, pre-dose on weeks 1,4,8,12,16,20,24,25,28 and 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 2 hours post dose on day 1, pre-dose on weeks 1,4,8,12,16,20,24,25,28 and 32 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period)

Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period)

Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters

+5 more

Secondary outcome measures

Absolute Value of CD4+ at Week 32 (Maintenance Period)

Absolute Value of Plasma HIV-1 RNA at Week 32 (Maintenance Period)

Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)

+52 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks (Q8W)Experimental Treatment4 Interventions

In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subject will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subject will receive following IM doses: Day 1 only - GSK744 LA 800 mg (loading dose delivered as two 400 mg IM injections) + TMC278 LA 900 mg IM. Week 4 only - GSK744 LA 600 mg IM (second loading dose, no TMC278).Week 8 - GSK744 LA 600 mg IM + TMC278 LA 900 mg IM every 8 weeks for 96 weeks.

Group II: GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks (Q4W)Experimental Treatment4 Interventions

In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subjects will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subjects will receive following IM doses: Day 1 only - GSK744 LA 800 mg (loading dose delivered as two 400 mg IM injections) + TMC278 LA 600 mg IM. Week 4 - GSK744 LA 400 mg IM + TMC278 LA 600 mg IM every 4 weeks for 96 weeks

Group III: Oral Control ArmActive Control3 Interventions

In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subjects will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subjects will receive an oral regimen of 30 mg of GSK744 and ABC/3TC once daily for 96 weeks (or 104 weeks if going on to the Extension Period)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RPV

2014

Completed Phase 2

~530

GSK744 LA

2014

Completed Phase 2

~310

TMC278 LA

2014

Completed Phase 2

~310

ABC/3TC

2015

Completed Phase 4

~2630

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor

80 Previous Clinical Trials

204,762 Total Patients Enrolled

ViiV HealthcareLead Sponsor

360 Previous Clinical Trials

468,270 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,507 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with taking GSK744 LA?

"GSK744 LA is still in the early stages of clinical testing, so it received a score of 2."

Answered by AI

How many people are receiving treatment as part of this research program?

"This specific study is not currently looking for participants, however it is worth noting that there are 1434 trials actively seeking patients with hiv infections and 21 studies involving GSK744 LA that are still recruiting."

Answered by AI

In how many different healthcare facilities is this research project being conducted presently?

"There are 20 different sites conducting this clinical trial. Some of the locations where patients can receive treatment include Birmingham, Providence and Vancouver. To minimize burdens related to travel, it is recommended that participants select the clinic nearest them."

Answered by AI

What is GSK744 LA most commonly used to treat?

"GSK744 LA can be used as a treatment for patients that have failed other methods of HIV treatment, those with viral resistance, and individuals that test negative for the virus."

Answered by AI

Do we have any other previous research to compare these results to?

"The initial study for GSK744 LA took place 19 years ago at the University of Zurich. In total, there have been 77 completed trials since then. Right now, 21 clinical trials are ongoing; a large proportion of these studies take place in Birmingham, Alabama."

Answered by AI

Are there any more patients needed to enroll in this research project?

"The clinicaltrials.gov website shows that this particular trial is not currently recruiting patients. The trial was initially posted on April 28th, 2014 and last updated on November 1st, 2022. Although this study isn't looking for participants anymore, there are still 1455 other trials open to patients right now."

Answered by AI

What are the goals of this research?

"The primary objective of this clinical trial is to assess the percentage of participants with plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) level below 50 copies/milliliter (c/mL) at Week 32. This will be monitored over a period of up to 59 weeks on average. Additionally, the study aims to observe the secondary objectives which include the percentage of participants with protocol defined virologic failure (PDVF) at Week 32 by subgroups and change from baseline in hematology parameters: hematocrit and mean corpuscle volume at week 32."

Answered by AI

Recent research and studies

Plos OneJournal

Experiences with Long Acting Injectable ART: A Qualitative Study Among PLHIV Participating in a Phase II Study of Cabotegravir + Rilpivirine (LATTE-2) in the United States and Spain

Kerrigan, Deanna, Andrea Mantsios, Miguel Gorgolas, Maria-Luisa Montes, Federico Pulido, Cynthia Brinson, Jerome deVente, et al.. 2018. “Experiences with Long Acting Injectable ART: A Qualitative Study Among PLHIV Participating in a Phase II Study of Cabotegravir + Rilpivirine (LATTE-2) in the United States and Spain”. Edited by Susan Marie Graham. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0190487.

Journal of Antimicrobial ChemotherapyJournal

Pharmacokinetics and Antiviral Activity of Cabotegravir and Rilpivirine in Cerebrospinal Fluid Following Long-acting Injectable Administration in Hiv-infected Adults

Letendre, Scott L, Anthony Mills, Debbie Hagins, Susan Swindells, Franco Felizarta, Jerome Devente, Christopher Bettacchi, et al.. 2019. “Pharmacokinetics and Antiviral Activity of Cabotegravir and Rilpivirine in Cerebrospinal Fluid Following Long-acting Injectable Administration in Hiv-infected Adults”. Journal of Antimicrobial Chemotherapy. Oxford University Press (OUP). doi:10.1093/jac/dkz504.

HIV Research & Clinical PracticeJournal

Patient-reported Tolerability and Acceptability of Cabotegravir + Rilpivirine Long-acting Injections for the Treatment of HIV-1 Infection: 96-week Results from the Randomized LATTE-2 Study

Murray, Miranda, Federico Pulido, Anthony Mills, Moti Ramgopal, Roger LeBlanc, Hans Jaeger, Viviam Canon, et al.. 2019. “Patient-reported Tolerability and Acceptability of Cabotegravir + Rilpivirine Long-acting Injections for the Treatment of HIV-1 Infection: 96-week Results from the Randomized LATTE-2 Study”. HIV Research & Clinical Practice. Informa UK Limited. doi:10.1080/25787489.2019.1661696.

The LancetJournal