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NCT03635788 · ClinicalTrials.gov registry record · Phase 3
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
A Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 3
- Development phase
- 456
- Enrollment target
- 20
- Study locations
NCT03635788: Active Phase 3 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03635788 is a Phase 3 study of HIV Infections that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 456 participants, roughly in line with the 445-participant average among 542 other HIV Infections trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635788, a Phase 3 study of HIV Infections, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 456 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Regimen failure was defined as the occurrence of the earlier of the following two events * virologic failure (defined as two consecutive HIV-1 RNA \>200 copies/mL after Step 2 randomization * Permanent discontinuation of randomized study treatment prior to or at Week 48 visit Cumulative probability was calculated by Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Standard of Care (SOC) Oral ART
- DRUG Oral RPV
- DRUG Oral CAB
- DRUG RPV-LA Loading Dose
- DRUG CAB-LA Loading Dose
Study Locations (20)
California
- University of Southern California CRS - Los Angeles
- UCLA CARE Center CRS - Los Angeles
- UCSD Antiviral Research Center CRS - San Diego
- Ucsf Hiv/Aids Crs - San Francisco
- Harbor-UCLA CRS - Torrance
New York
- Weill Cornell Chelsea CRS - New York
- Columbia P&S CRS - New York
- Weill Cornell Uptown CRS - New York
- SUNY Stony Brook NICHD CRS - Stony Brook
Illinois
- Northwestern University CRS - Chicago
- Rush University CRS - Chicago
Massachusetts
- Massachusetts General Hospital CRS (MGH CRS) - Boston
- Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS - Boston
Alabama
- Alabama CRS - Birmingham
Colorado
- University of Colorado Hospital CRS - Aurora
Florida
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
Georgia
- The Ponce de Leon Center CRS - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2026-08-30 |
| Phase | Phase 3 |
What the registry record for NCT03635788 still lists
NCT03635788 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 445-participant average among 542 other HIV Infections trials with a reported enrollment target.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Standard of Care (SOC) Oral ART is the first listed.
NCT03635788 names 20 study sites across 11 states, led by California, New York, Illinois.
Frequently Asked Questions
What is clinical trial NCT03635788 about?
NCT03635788 is a clinical study titled "The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE". 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).
What is the current status of trial NCT03635788?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 456 participants. The study started on 2019-03-28. Estimated completion is 2026-08-30.
What conditions does trial NCT03635788 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT03635788?
The interventions under investigation include: Standard of Care (SOC) Oral ART (DRUG), Oral RPV (DRUG), Oral CAB (DRUG), RPV-LA Loading Dose (DRUG), CAB-LA Loading Dose (DRUG).
Who is sponsoring clinical trial NCT03635788?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03635788 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03635788's enrollment target sits among peer trials
456 72nd of 542 higher than 471 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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