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Antiretroviral Therapy
Long-Acting Antiretroviral Therapy for HIV
Phase 3
Recruiting
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
Age greater than or equal to 18 years
Ability to construct an oral induction antiretroviral regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up step 2 randomization, step 2 weeks 24 and 48
Awards & highlights
Study Summary
This trial will compare the efficacy of long-acting antiretroviral therapy to the standard of care in participants with a history of sub-optimal adherence and control of their HIV infection.
Who is the study for?
This trial is for adults with HIV who've struggled to stick to their oral ART medication. They must have a recent history of poor viral control or missed clinic visits, no resistance to certain HIV drugs, and acceptable blood test results. Pregnant or breastfeeding individuals, those with allergies to study drugs, chronic hepatitis C requiring treatment during the study, active hepatitis B infection, or conditions affecting drug injections are excluded.Check my eligibility
What is being tested?
The LATITUDE Study is testing long-acting antiretroviral therapy (LA ART) against standard oral ART in people with HIV who have trouble taking daily pills. It aims to see if LA injections can better manage their condition by comparing effectiveness and safety over time.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or swelling, potential liver enzyme changes indicating liver stress, fatigue, gastrointestinal issues such as nausea or diarrhea, and possibly allergic reactions for those sensitive to components in the medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can take HIV medication by mouth as part of my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ step 2 randomization, step 2 weeks 24 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~step 2 randomization, step 2 weeks 24 and 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of regimen failure in Step 2
Secondary outcome measures
Frequency of AEs during Steps 1 and 2
Frequency of Injection Site Reactions (ISR) during Step 2
Assisted Reproductive Technologies
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: LA ARTExperimental Treatment7 Interventions
In Step 1, participants will receive SOC oral ART regimen for up to 24 weeks. In Step 2, participants will receive oral RPV once daily and oral CAB once daily for 4 weeks (optional), followed by a RPV-LA loading dose and a CAB-LA loading dose, followed in 4 weeks by an RPV-LA maintenance dose and a CAB-LA maintenance dose every 4 weeks for 44 weeks. In Step 3, participants will receive a RPV-LA maintenance dose and a CAB-LA maintenance dose every 4 weeks until the end of Step 2. In Step 4, eligible participants will be followed until they complete 52 weeks on locally sourced oral ART.
Group II: Arm B: SOC Oral ARTActive Control7 Interventions
In Step 1, participants will receive SOC oral ART regimen for up to 24 weeks. In Step 2, participants will continue SOC oral ART regimen for 52 weeks. In Step 3, participants will receive oral RPV once daily and oral CAB once daily for 4 weeks (optional), followed by a RPV-LA loading dose and a CAB-LA loading dose, followed in 4 weeks by an RPV-LA maintenance dose and CAB-LA maintenance dose every 4 weeks until the end of Step 3. In Step 4, eligible participants will be followed until they complete 52 weeks on locally sourced oral ART.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral CAB
2018
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,137 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
360 Previous Clinical Trials
468,229 Total Patients Enrolled
Jose Castillo-Mancilla, M.D.Study ChairUniversity of Colorado Hospital CRS
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tests show no resistance mutations relevant to my treatment.I have not consistently followed my HIV treatment plan.I have chronic Hepatitis C and plan to start treatment.I need long-term blood thinner medication.I am 18 years old or older.I have advanced liver disease or a history of liver cirrhosis.I have an active hepatitis B infection.I do not have any serious health or mental conditions that could affect my participation.I am not taking any medications that are not allowed in the study.My recent tests show no resistance to certain HIV medications.I can take HIV medication by mouth as part of my treatment.I am at high risk for seizures.My HIV does not have resistance mutations based on recent or past tests.My doctor and I can create an HIV treatment plan with at least three effective drugs.I have a confirmed HIV-1 infection.My HIV has not responded well to treatment in the last 18 months.I cannot receive injections or specifically in the buttocks.I have missed taking my HIV medication as prescribed in the last 18 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: SOC Oral ART
- Group 2: Arm A: LA ART
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT03635788 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions does Standard of Care (SOC) Oral ART typically address?
"Standard of Care (SOC) Oral ART can be used to effectively treat patients that test negative for HIV, have treatment failure, or experience viral resistance."
Answered by AI
Are there any available spots for this experimental treatment?
"That is accurate. The clinical trial, which was posted on March 28th, 2019 and updated December 1st, 2021, is currently looking for 350 patients at 32 different locations."
Answered by AI
What are the risks associated with the current standard of care for oral HIV treatment?
"Standard of Care (SOC) Oral ART has received a score of 3 for safety. This is due to the Phase 3 status of the trial, which implies that there is some data supporting efficacy and that multiple rounds of data support safety."
Answered by AI
Could you inform me how many hospitals are currently testing this procedure?
"Enrolling patients can be found at 32 locations, which include the Alabama CRS in Birmingham, the Johns Hopkins University CRS in Baltimore, and the Northwestern University CRS in Chicago, among other sites."
Answered by AI
Are there other research projects which compare the standard oral medication to other treatments?
"Standard of Care Oral ART was first investigated in 2002 at University of Zurich. As of now, 71 clinical trials have been completed with 21 more ongoing. The global locations of these studies are varied, though many are based in Birmingham, Alabama."
Answered by AI
Who else is applying?
What state do they live in?
New York
Illinois
California
How old are they?
18 - 65
What site did they apply to?
Ucsf Hiv/Aids Crs
University of Colorado Hospital CRS
Weill Cornell Chelsea CRS
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
HIV can suck. I have taken 3 medication.
PatientReceived 2+ prior treatments
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