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The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

NCT03635788 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2025-09-02

Study results available
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Summary

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).

Conditions

  • HIV Infections

Interventions

DRUG

Standard of Care (SOC) Oral ART

SOC oral ART regimen must include at least 3 drugs with 2 or more drugs predicted to be fully active, including a boosted protease inhibitor (PI) and/or an integrase strand transfer inhibitor (INSTI)

DRUG

Oral RPV

RPV 25 mg tablets

DRUG

Oral CAB

CAB 30 mg tablets

DRUG

RPV-LA Loading Dose

900 mg administered as one 3 mL (900 mg) intramuscular injection in the gluteal muscle

DRUG

CAB-LA Loading Dose

600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle

DRUG

RPV-LA Maintenance Dose

600 mg administered as one 2 mL (600 mg) intramuscular injection in the gluteal muscle

DRUG

CAB-LA Maintenance Dose

400 mg administered as one 2 mL (400 mg) intramuscular injection in the gluteal muscle

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Aadia Rana, M.D. · Alabama CTU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2024-02-12
Completion
2026-08-30
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635788 on ClinicalTrials.gov