456 Participants Needed

Long-Acting Antiretroviral Therapy for HIV

Recruiting at 30 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you must not require any medication that is prohibited with the study medication, so it's best to discuss your current medications with the study team.

Is long-acting antiretroviral therapy for HIV safe for humans?

Long-acting antiretroviral therapy using cabotegravir (CAB-LA) and rilpivirine (RPV-LA) has been generally well-tolerated in clinical trials, with safety profiles similar to placebo, meaning they did not cause more side effects than a non-active treatment. These treatments have been approved for use in people with HIV who have their virus under control, and further studies are ongoing to confirm their safety in broader populations.12345

How is the long-acting antiretroviral therapy for HIV different from other treatments?

This treatment is unique because it involves long-acting injectable forms of cabotegravir and rilpivirine, which are administered every 4 or 8 weeks, reducing the need for daily pills. This can improve adherence and quality of life for patients who struggle with daily medication routines.45678

What data supports the effectiveness of the long-acting antiretroviral therapy for HIV?

Research shows that the long-acting injectable combination of cabotegravir and rilpivirine is as effective as daily oral antiretroviral therapy for maintaining HIV suppression, offering a convenient option for those who struggle with daily medication adherence.45679

Who Is on the Research Team?

AR

Aadia Rana, M.D.

Principal Investigator

Alabama CTU

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Laboratory values within specified ranges
HIV-1 infection confirmed by licensed tests
Agreement to use contraception for participants of reproductive potential
See 6 more

Exclusion Criteria

I have chronic Hepatitis C and plan to start treatment.
I need long-term blood thinner medication.
I have advanced liver disease or a history of liver cirrhosis.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive a SOC oral ART regimen with conditional economic incentives for up to 24 weeks

24 weeks
Regular visits for monitoring and incentives

Randomization and Treatment

Participants are randomized to either LA ART or SOC. LA ART involves oral RPV + CAB for 4 weeks (optional) followed by RPV-LA + CAB-LA every 4 weeks. SOC continues for 52 weeks.

52 weeks
Monthly visits for LA ART injections or regular visits for SOC monitoring

Continuation/Crossover

Participants on LA ART continue for 52 weeks. SOC participants may cross over to LA ART if criteria are met.

52 weeks
Monthly visits for LA ART injections

Observation

Participants are followed on locally sourced oral ART for up to 52 weeks. Option to restart LA ART if available.

52 weeks
Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CAB-LA Loading Dose
  • CAB-LA Maintenance Dose
  • Oral CAB
  • Oral RPV
  • RPV-LA Loading Dose
  • RPV-LA Maintenance Dose
  • Standard of Care (SOC) Oral ART
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Step 2 Arm A: LA ARTExperimental Treatment6 Interventions
In Step 2, participants received 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.
Group II: Step 1 SOCExperimental Treatment1 Intervention
In Step 1, participants received SOC oral ART regimen for up to 24 weeks.
Group III: Step 2 Arm B: SOCActive Control1 Intervention
In Step 2, participants continued SOC oral ART regimen for 52 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

ViiV Healthcare

Industry Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Published Research Related to This Trial

65.8% of people living with HIV expressed interest in trying a long-acting regimen (LAR) of cabotegravir and rilpivirine, particularly those with unmet needs such as suboptimal adherence and privacy concerns.
Physicians showed a high willingness to offer LAR in cases of strong medical need and for patients with adherence issues, indicating that this treatment could significantly improve patient quality of life and adherence to HIV therapy.
Factors associated with interest in a long-acting HIV regimen: perspectives of people living with HIV and healthcare providers in four European countries.Akinwunmi, B., Buchenberger, D., Scherzer, J., et al.[2021]
Long-acting injectable cabotegravir (CAB) combined with rilpivirine (RPV) is an effective maintenance therapy for HIV suppression in patients who have maintained an undetectable viral load for 3 to 6 months, providing an alternative to daily oral medications.
There is a growing interest in developing new long-acting injectable antiretroviral agents with different mechanisms of action, which are currently being tested in phase 2 and 3 clinical trials to further improve treatment options for patients unable to adhere to daily oral therapy.
Long-Acting Injectable Antiretroviral Agents for HIV Treatment and Prevention.Kim, YS.[2022]
Long-acting injectable antiretroviral (ARV) treatments, like cabotegravir/rilpivirine (LA-CAB/RPV), offer a simplified alternative to daily oral medications for HIV, potentially improving adherence and health outcomes for patients.
LA-CAB/RPV is currently the only approved long-acting injectable regimen for HIV treatment in adults and adolescents who are already virologically suppressed, with ongoing studies exploring its use in broader populations.
Long-acting injectable antiretroviral therapy: will it change the future of HIV treatment?Brizzi, M., Pérez, SE., Michienzi, SM., et al.[2023]

Citations

Factors associated with interest in a long-acting HIV regimen: perspectives of people living with HIV and healthcare providers in four European countries. [2021]
Long-Acting Injectable Antiretroviral Agents for HIV Treatment and Prevention. [2022]
Long-acting injectable antiretroviral therapy: will it change the future of HIV treatment? [2023]
Identifying appropriate candidates for long-acting antiretroviral therapy: findings from a survey of health care providers in the ATLAS-2M trial. [2021]
Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M). [2022]
Safety and Pharmacokinetic Profiles of Long-Acting Injectable Antiretroviral Drugs for HIV-1 Pre-Exposure Prophylaxis: A Systematic Review and Meta-analysis of Randomized Trials. [2021]
Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. [2022]
Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. [2023]
Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. [2022]
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