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Compares treatment options for HIV-1-infection
Official title 2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
ClinicalTrials.gov ID: NCT04553081
What this study is testing
What is Dual versus triple therapy in treatment of HIV-1 infection.?
Dual versus triple therapy in treatment of HIV-1 infection. is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv-1-infection.
Also referred to as not applicatble.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether this has an influence on different parameters such as severity of HIV disease (evaluated by viral load and viral reservoir size), presence of non-AIDS related health complications, impact the phenotype and function of the immune system.
- Phase 4: studies an already-approved treatment
- Time commitment: about 48 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age = or \>18 years.
- Ability and willingness to provide written informed consent.
- Ability to attend the complete schedule of assessments and patient visits.
- Ability and willingness to have blood samples collected and stored indefinitely and used for various research purposes.
- HIV RNA \< 50 copies/mL for at least 3 months on a 2nd generation INSTI based regimen.
You likely can't join if
- Current presence of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification).
- Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent...
- Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV...
- Pregnancy or breastfeeding.
- Patients unable to understand the study protocol or any other condition that in the investigator's opinion may compromise compliance with the study...
- Decompensated liver cirrhosis (Child-Pugh B/C)
See the full eligibility criteria
- Age = or \>18 years.
- Ability and willingness to provide written informed consent.
- Ability to attend the complete schedule of assessments and patient visits.
- Ability and willingness to have blood samples collected and stored indefinitely and used for various research purposes.
- HIV RNA \< 50 copies/mL for at least 3 months on a 2nd generation INSTI based regimen.
- Females of childbearing potential should be on effective contraception
- Current presence of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification).
- Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (seroconversion= HBV antigen or viral load negative and positive...
- Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior...
- Pregnancy or breastfeeding.
- Patients unable to understand the study protocol or any other condition that in the investigator's opinion may compromise compliance with the study protocol
- Decompensated liver cirrhosis (Child-Pugh B/C)
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from...
- Psychiatric and psychological disorders, which in the opinion of the investigator, will interfere with the trial conduct or safety of the participant.
- Previous participation in a trial evaluating an immune modulating agent.
- Active drug or alcohol use/addiction such that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Treatment failure on an integrase inhibitor containing regimen and reported baseline resistance
- Creatinine Clearance \<50
- Tuberculosis treatment
- Documented M184V
- Previous virological failure \>200 copies/mL on NRTI
- people with history or presence of allergy to any of the study drugs or their components
- ALT \>5 times the ULN, OR ALT \>3xULN and bilirubin \>1.5xULN (with \>35% direct bilirubin)
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.