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NNRTI

DOR/3TC/TDF for Weight Management in HIV (DeLiTE Trial)

Phase 4
Waitlist Available
Led By Sharon Walmsley
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Significant weight gain since initiation of the INSTI-based regimen (>10% of baseline body weight)
On an Integrase Strand Transfer Inhibitor (INSTI) based regimen for at least 1 year and less than 5 years prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

DeLiTE Trial Summary

This trial is designed to determine whether switching patients who are gaining weight on an integrase inhibitor-based regimen to a different regimen for one year can help to slow down or even reverse the weight gain.

Who is the study for?
This trial is for adults with HIV who've been on an INSTI-based regimen for 1-5 years and gained significant weight (>10% of baseline). They must have a stable viral load (<200 copies/mL) for over 6 months, no history of ART resistance to the study drugs, not pregnant or planning pregnancy within a year, and using contraception if applicable.Check my eligibility
What is being tested?
The study tests if switching from an INSTI-based regimen to DOR/3TC/TDF (Doravirine/Lamivudine/Tenofovir DF) can stop or reverse weight gain in HIV patients. It's a pilot study providing data to plan a larger trial.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical antiretroviral therapy reactions such as gastrointestinal issues, headaches, fatigue, and possible drug interactions affecting kidney function.

DeLiTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have gained more than 10% of my body weight since starting my INSTI-based treatment.
Select...
I have been on an INSTI-based treatment for 1-5 years.

DeLiTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identify factors associated with early study discontinuation.
Identify number of active clinic patients who meet eligibility criteria, and of those approached, how many accepted enrollment and completed the study protocol.
Identify reasons for study ineligibility among clinic patients on INSTI-containing regimen who have experienced weight gain.
+1 more
Secondary outcome measures
Acquired Immunodeficiency Syndrome
To determine the change in BMI category from baseline to one year following the switch from the INSTI-containing regimen to DOR/TDF/3TC.
To determine the change in absolute weight from baseline to one year following the switch from the INSTI-containing regimen to DOR/TDF/3TC.
+3 more
Other outcome measures
To determine the impact from baseline to one year following the switch from the INSTI-containing regimen to DOR/TDF/3TC on DXA body scans.
To determine the impact from baseline to one year following the switch from the INSTI-containing regimen to DOR/TDF/3TC on fasting glucose values.
Insulin
+3 more

DeLiTE Trial Design

1Treatment groups
Experimental Treatment
Group I: DOR/3TC/TDFExperimental Treatment1 Intervention
100mg of doravirine (DOR), 300mg of lamivudine (3TC), and 300mg of tenofovir disoproxil fumarate (TDF)

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,848 Total Patients Enrolled
Merck Canada Inc.Industry Sponsor
11 Previous Clinical Trials
1,493 Total Patients Enrolled
Sharon WalmsleyPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
146 Total Patients Enrolled

Media Library

Doravirine/Lamivudine/Tenofovir DF (NNRTI) Clinical Trial Eligibility Overview. Trial Name: NCT04665375 — Phase 4
HIV (Human Immunodeficiency Virus) Research Study Groups: DOR/3TC/TDF
HIV (Human Immunodeficiency Virus) Clinical Trial 2023: Doravirine/Lamivudine/Tenofovir DF Highlights & Side Effects. Trial Name: NCT04665375 — Phase 4
Doravirine/Lamivudine/Tenofovir DF (NNRTI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04665375 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size for this clinical research endeavor?

"Currently, this clinical trial is not enrolling patients. It was first posted on April 26th 2021 and last modified on May 17th 2022. If you are looking for alternative studies, there are 258 trials actively recruiting participants with weight gain issues and 93 trials with DOR/3TC/TDF available to join."

Answered by AI

Is the combination of DOR/3TC/TDF an accepted pharmaceutical protocol?

"There is a substantial body of evidence that confirms the safety and efficacy of DOR/3TC/TDF, hence it was rated 3 on our 1-to-3 scale."

Answered by AI

How is the drug combination of DOR/3TC/TDF traditionally used?

"DOR/3TC/TDF is routinely used for conditions where there are no doravirine resistance-associated mutations present. It can also help patients suffering from HIV, treatment failure or high risk cases."

Answered by AI

To what extent have previous explorations explored the efficacy of DOR/3TC/TDF?

"Presently, there are 93 active clinical trials for DOR/3TC/TDF with 35 of those in Phase 3. The epicenter is Boylston, Massachusetts; yet across the country 1480 sites are running experiments involving this medical intervention."

Answered by AI

What specific goals is this clinical trial attempting to fulfill?

"The primary aim of this evaluation, which will span the course of a year, is to detect factors related to premature trial cessation. Secondary objectives include assessing relative weight alteration per annum compared with baseline data; absolute body mass at 48 weeks in comparison to baseline values sans outside clothing, purses and accessories; and ascertaining the proportion of participants who sustain viral suppression (HIV RNA < 50 copies/ml) after transitioning from INSTI-containing medication regimens to DOR/TDF/3TC."

Answered by AI

Is the recruitment process for this clinical trial still ongoing?

"This particular medical trial is no longer taking new patients. It was initially posted on April 26th 2021, and its most recent updates were made on May 17th 2022. If you're looking for alternative studies, there are currently 258 trials recruiting participants with weight gain issues and 93 more for DOR/3TC/TDF treatments that still need volunteers."

Answered by AI
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~3 spots leftby Aug 2024