Long-Acting Antiretroviral Therapy for HIV

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is 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).

Eligibility Criteria

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

+7 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.

+8 more

Participant Groups

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.

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.