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Antiretroviral Therapy

Long-Acting Antiretroviral Therapy for HIV

Phase 3

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

Age greater than or equal to 18 years

Ability to construct an oral induction antiretroviral regimen

Must not have

Chronic Hepatitis C with planned anti-HCV therapy

Need for chronic anti-coagulation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up step 2 randomization, step 2 weeks 24 and 48

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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I am 18 years old or older.

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I can take HIV medication by mouth as part of my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have chronic Hepatitis C and plan to start treatment.

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I need long-term blood thinner medication.

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I have advanced liver disease or a history of liver cirrhosis.

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I have an active hepatitis B infection.

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I am not taking any medications that are not allowed in the study.

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I am at high risk for seizures.

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I cannot receive injections or specifically in the buttocks.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and step 2 randomization, step 2 weeks 24 and 48 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Occurrence of regimen failure in Step 2

Secondary study objectives

Frequency of AEs during Steps 1 and 2

Frequency of Injection Site Reactions (ISR) during Step 2

Assisted Reproductive Technologies

+9 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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

Standard of Care (SOC) Oral ART

2019

Completed Phase 2

~80