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Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

NCT04892654 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-10-25

No results posted yet for this study

Summary

Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of cART can lead to side-effects through exposure to drug-related toxicity.

For this reason researchers are interested in looking at alternative therapies that might expose patients to fewer and less severe side effects while providing the same quality of care as antiretroviral therapies most often used to treat HIV.

The purpose of this study is to investigate if the study drug combination that is being tested (doravirine + dolutegravir) is safe compared with other triple cART regimens.

Conditions

Interventions

DRUG

Doravirine

Antiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor

DRUG

Dolutegravir

Antiretroviral, Integrase strand transfer inhibitors

OTHER

Triple cART regimen

Participant standard triple cART regimen

Sponsors & Collaborators

  • Chelsea and Westminster NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Marta Boffito, MD PhD FRCP · Chelsea and Westminster NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2026-11-30
Completion
2027-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04892654 on ClinicalTrials.gov