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Integrase Inhibitor

Long-Acting HIV Drugs for HIV

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NOTE: One plasma HIV-1 RNA greater than or equal to 50 copies/mL but less than 200 copies/mL is allowed if followed by a subsequent HIV-1 RNA value below 50 copies/mL.

Adequate venous access in at least one arm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured through week r3+48 of step 3

Awards & highlights

Study Summary

This trial will test a new, long-acting drug combination to treat HIV-1 in adults with suppressed plasma viremia.

Who is the study for?

Adults living with HIV-1 who have maintained a viral load under 50 copies/mL for the past two years, are clinically stable on ART (antiretroviral therapy) including two NRTIs, and have CD4+ T-cell counts above 350 cells/mm^3. Participants must not be pregnant or breastfeeding, agree to use contraception, and have no history of severe allergic reactions or certain other health conditions.Check my eligibility

What is being tested?

The trial is testing the combination of long-acting injectable Cabotegravir (CAB LA) with a monoclonal antibody VRC07-523LS against standard oral antiretroviral therapy. The goal is to see if this new regimen can maintain viral suppression in those already stable on current HIV treatments.See study design

What are the potential side effects?

Potential side effects may include injection site reactions from CAB LA, immune system changes due to VRC07-523LS, possible liver enzyme alterations, fatigue, and gastrointestinal issues. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My HIV viral load was once between 50-200 copies/mL but is now under 50 copies/mL.

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I can have needles inserted into my arm veins without issue.

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I am willing and able to continue my current two NRTIs treatment.

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I have a confirmed HIV-1 infection.

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I've been stable on my current HIV treatment for at least 8 weeks without changing it due to failure.

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My recent CD4+ T-cell count is 350 or higher.

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I have been stable on a three-drug HIV treatment for at least 8 weeks.

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I meet the initial requirements to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured through week r3+48 of step 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured through week r3+48 of step 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through week r3+48 of step 3 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency of either 1) the occurrence of a Grade 3 or higher adverse event (AE); or 2) premature study treatment discontinuation due to an AE (regardless of grade)

Secondary outcome measures

Frequency of anti-idiotype antibodies against VRC07-523LS in samples collected from representative time points throughout the study

Frequency of either 1) the occurrence of a Grade 3 or higher AE; or 2) premature oral CAB discontinuation due to an AE (regardless of grade)

Frequency of either 1) virologic failure (confirmed HIV-1 RNA greater than or equal to 200 copies/mL); or 2) premature discontinuation of the CAB LA plus VRC07-523LS combination

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CAB LA + VRC07-523LSExperimental Treatment5 Interventions

Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for 5 weeks. Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44. VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40. Step 3: SOC oral ART regimen for approximately 48 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VRC07-523LS

2019

Completed Phase 1

~310

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,481,057 Total Patients Enrolled

ViiV HealthcareIndustry Sponsor

359 Previous Clinical Trials

468,468 Total Patients Enrolled

Pablo Tebas, MDStudy ChairHospital of the University of Pennsylvania CRS

18 Previous Clinical Trials

515 Total Patients Enrolled

Media Library

Cabotegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03739996 — Phase 2

Human Immunodeficiency Virus Infection Research Study Groups: CAB LA + VRC07-523LS

Human Immunodeficiency Virus Infection Clinical Trial 2023: Cabotegravir Highlights & Side Effects. Trial Name: NCT03739996 — Phase 2

Cabotegravir (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739996 — Phase 2

Frequently Asked Questions

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

Has this research been done before?

"Since 2014, Standard of Care (SOC) Oral ART has undergone extensive research with the first study being sponsored by Janssen Pharmaceuticals. In total, there have been 16 active trials spanning 155 cities and 30 countries. As a result of the initial trial in 2014 involving 309 patients, this medication received Phase 2 drug approval."

Answered by AI

Are there any other ongoing research projects that compare different treatments for HIV patients?

"Standard of Care (SOC) Oral ART was first studied in 2014 at GSK Investigational Site. So far, there have been 27 completed clinical trials. Presently, 16 live clinical trials are underway; many of these taking place in New york City."

Answered by AI

How many people are signing up for this clinical trial?

"This study has closed recruitment and is not currently looking for any more participants. The clinical trial was first posted on December 31st, 2019 and updated for the last time on November 10th, 2022. There are 499 other trials concerning HIV infection and 16 Standard of Care Oral ART trials that are still recruiting patients."

Answered by AI

Is the Standard of Care Oral ART treatment plan approved by the FDA?

"Standard of Care (SOC) Oral ART has only been proven safe in clinical trials, not effective. Our team rated it a 2."

Answered by AI

What do medical professionals usually prescribe Standard of Care (SOC) Oral ART for?

"The Standard of Care (SOC) Oral ART is a common treatment for hiv test negative. This course of care can also be used to effectively treat weight at least 35 kg, treatment failure, and virologically-supressed patients."

Answered by AI

In how many different locations is this trial being conducted?

"Currently, there are 19 sites running this study. They are based in New york, Birmingham and Aurora as well as other cities 19 other locations. If you enroll in the study, try to select the location nearest you to reduce travel time commitments."

Answered by AI

Can patients join in this research right now?

"According to the latest update on clinicaltrials.gov, this trial is not currently looking for participants. Although 515 other trials are still recruiting patients, this particular study has not been since November 10th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

2019. "Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03739996.

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