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TerminatedNCT04665375DeLiTEUpdated Jul 16, 2025Results posted

Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF?

A Phase 4 interventional study of DOR/3TC/TDF in Hiv and Weight Gain, sponsored by University Health Network, Toronto. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Treatment

Why this study was terminated
enrollment futility
Phase
Phase 4
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Weight gain with the integrase inhibitors and tenofovir alafenamide has been observed in observational cohorts and randomized controlled clinical trials. Although some risk factors have been identified, the cause is unknown and it remains to be determined if the changes are reversible. The weight gain is of concern to persons living with HIV. This pilot intervention study is designed to provide preliminary data on whether switching patients with weight gain on an INSTI-based regimen to a combination of doravirine/tenofovir disoproxil fumarate/lamivudine (DOR/3TC/TDF, an NNRTI-based regimen) for one year can slow down or even reverse weight gain. These data will then be used to inform the design and sample size of a larger switch study.

Read the detailed description

Background and Importance: Lifelong antiretroviral treatment (ART) is recommended for all people living with HIV (PLWH) primarily with integrase strand inhibitor (INSTI)-based regimens. While weight gain following ART initiation was previously considered "return to health", recent studies have raised concerns of weight gain and increasing obesity in PLWH, most notably with INSTIs and possibly with tenofovir alafenamide (TAF), a preferred nucleoside backbone agent. The weight gain may be progressive and may increase cardiovascular risk. A critical unanswered question is whether weight gain and metabolic effects are permanent or reversible. This data is crucial to optimize ART therapy and health of PLWH.

Goal/Research Aims: No therapeutic alternatives are substantiated for ART-associated weight gain. Doravirine/lamivudine/tenofovir DF (DOR/3TC/TDF) is an attractive option to explore as it does not include an INSTI or TAF, is a well tolerated once daily single tablet, minimal drug interactions and has not been associated with significant weight gain to date. The investigators hypothesize that switching from an INSTI regimen to DOR/3TC/TDF will slow or reverse weight gain while maintaining viral suppression. Before embarking on a large randomized controlled study (RCT), the investigators propose this pilot study to determine the feasibility and acceptability and to obtain estimate measures of weight change to inform its design and sample size.

Methods: Open-label, exploratory pilot switch study. Patients who are virally suppressed on an INSTI regimen for >1 year, without ART resistance, and have experienced significant weight gain will be approached to switch to DOR/3TC/TDF for 48 weeks. Weight, adherence, viral load, CD4, and other relevant labs will be measured every 3 months. A DXA body scan and body image questionnaires will be completed at baseline and 12 months. The anticipated sample size is 25 with an aim to recruit 50% male, 50% female.

The primary objective is to determine what proportion of clinic patients meet eligibility criteria, agree to participate, and complete the study. The secondary objective is to estimate the distribution of various weight-related outcomes while on DOR/3TC/TDF compared to previous INSTI regimens. Exploratory outcomes will address metabolic changes and body image impact.

02

Conditions studied

  • Hiv
  • Weight Gain

Keywords

  • weight gain
  • HIV
  • doravirine
  • integrase inhibitor
  • tenofovir alafenamide
  • tenofovir disoproxil fumarate
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 4 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented HIV-1 infection by means of any one of the following:

Documentation of HIV diagnosis in the medical record by a licensed health care provider; OR HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL; OR any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid Multispot antibody differentiation assay.

  • On an Integrase Strand Transfer Inhibitor (INSTI) based regimen for at least 1 year and less than 5 years prior to screening
  • Significant weight gain since initiation of the INSTI-based regimen (>10% of baseline body weight)
  • Viral load of \<200 copies/mL for > 6 consecutive months prior to screening (single viral blips \<200 copies/mL accepted if re-suppressed)
  • Documentation of weight, glycemia, cholesterol, and blood pressure (BP) history within the last year.
  • Signed Informed Consent Form (Appendix B) and willing to comply with the protocol.
  • Using proper contraception if of child bearing age and potential.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or desire to become pregnant within the next year
  • Failure to use adequate contraception during the study if of child-bearing potential.
  • Any underlying documented ART resistance to doravirine, tenofovir disoproxil fumarate, or lamivudine
  • Prior virologic failure
  • Concomitant drugs that interact with doravirine
  • Initiated on concomitant drugs known to cause weight gain within the last 6 months (i.e. antidepressants and antipsychotics)
  • Concomitant drugs known to cause nephrotoxicity
  • History of renal toxicity or renal events while on TDF therapy.
  • Creatinine clearance (CrCL) \< 50 mL/min
  • Inability to read/understand English
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    DOR/3TC/TDF

    100mg of doravirine (DOR), 300mg of lamivudine (3TC), and 300mg of tenofovir disoproxil fumarate (TDF)

    Drug: DOR/3TC/TDF

Interventions

  • DrugDOR/3TC/TDF

    switch antiretroviral regimen to doravirine/lamivudine/tenofovir disoproxil fumarate once daily for 1 year

    Also known as: Delstrigo

06

What researchers measure

Primary outcomes

  1. Identify Number of Active Clinic Patients Who Completed the Study Protocol.

    The primary objective was to determine how many clinic patients with ≥10% weight gain on an INSTI would complete the study (48 weeks).

    Time frame: 1 year

  2. Identify Reasons for Study Ineligibility Among Clinic Patients on INSTI-containing Regimen Who Have Experienced Weight Gain.

    Descriptive data. Reasons for study ineligibility (i.e., not meeting inclusion criteria or presence of one or more exclusion criteria) will be recorded by the study coordinator.

    Time frame: 1 year

  3. Identify Reasons for Study Refusal Among Clinic Patients on INSTI-containing Regimen Who Have Experienced Weight Gain.

    Descriptive data. Clinic patients who refuse to participate in the study will be asked an open-ended question by the study coordinator about main reason(s) for declining. Responses will be grouped by the following categories: fear of side effects, distrust of researchers, general concerns about research design, interference in everyday life or changes in routine, and social discrimination.

    Time frame: 1 year

  4. Identify Factors Associated With Early Study Discontinuation.

    Factors will include age, gender, race, CD4 count, HIV viral load, prior enrollment in a study, history of injection drug use, and use of antidepressants.

    Time frame: 1 year

Secondary outcomes

  1. To Determine the Change in Absolute Weight From Baseline to One Year Following the Switch to DOR/TDF/3TC.

    Absolute weight (kg) at one year minus weight at baseline (kg).

    Time frame: 1 year

  2. Number of Participants Who Experienced a Change in Weight After a Switch to DOR/TDF/3TC at 1 Year

    To determine the number of participants who experienced either an increase, decrease or no change in weight (weight at 1 year vs. weight at baseline) following the switch to DOR/TDF/3TC.

    Time frame: 1 year

  3. Change in Waist Circumference From Baseline to One Year Following the Switch to DOR/TDF/3TC.

    Change in waist circumference (value at 1 year minus value at baseline) will be reported. Waist circumference to be measured using a landmark just above the uppermost lateral border of the right ilium (under the participant's clothing). Measurement will be recorded to the nearest tenth of a centimeter at the end of the participant's normal expiration.

    Time frame: 1 year

  4. Number of Participants Who Experienced a Change in BMI Category After a Switch to DOR/TDF/3TC at One Year

    Number of participants with a change in BMI category (BMI category at one year compared to BMI category at baseline) following the switch to DOR/TDF/3TC.

    Time frame: 1 year

  5. Number of Participants Who Maintain HIV RNA<50 Copies/mL After a Switch to DOR/TDF/3TC at 1 Year

    To determine the number of participants who maintain viral suppression (HIV RNA \< 50 copies/ml using Abbott RealTime HIV-1 assay) at 1 year after a switch to DOR/TDF/3TC.

    Time frame: 1 year

  6. Number of Patients With Treatment-related Adverse Events

    Adverse event parameters graded according to severity: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening), Grade 5 (death) as assessed by the US DHHS NIH/NIAID Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1 (July 2017)

    Time frame: 1 year

Other outcomes

  1. Loss of Percentage of Total Body Fat From Baseline to One Year

    loss of percentage of total body fat (difference at one year minus from baseline) following the switch from the INSTI-containing regimen to DOR/TDF/3TC according to DXA body scans.

    Time frame: 1 year

  2. Change in Self-esteem Related to Body Image as Per the Body Image Questionnaire B-WISE at One Year Versus Baseline.

    The Body Weight, Image and Self-Esteem (B-WISE) questionnaire is a validated 12-item, self-administered questionnaire that assesses body image and self-esteem related to weight gain. It was selected to assess impact of weight gain/change in our study. B-WISE scores range between 12-36; higher scores are indicative of better psychosocial adjustment (12-20 = severe; 21-28 = moderate; 29-36 = mild). The change in total B-WISE scores (value at one year minus value at baseline) will be calculated.

    Time frame: 1 year

  3. To Determine the Change in Perceived Changes in Body Size as Per the FRAM Body Image Questionnaire

    The change in FRAM scores (value at one year minus baseline value) will be measured.

    Time frame: 1 year

  4. Change in Fasting Glucose Values Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC

    The change in fasting blood glucose (value at one year minus baseline value) will be measured.

    Time frame: 1 year

  5. To Determine the Impact From Baseline to One Year Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC on Insulin Resistance (HOMA-IR).

    HOMA score: fasting plasma glucose (mmol/L) times fasting serum insulin (mU/L) divided by 22.5. A score of \<3 indicates normal insulin resistance, a score between 3 and -5 indicates moderate insulin resistance, and a score \>5 indicates severe insulin resistance.

    Time frame: 1 year

  6. To Determine the Impact From Baseline to One Year Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC on Lipid Values (Standard Lipid Panel).

    Standard lipid panel includes total cholesterol, HDL, LDL, triglycerides (all mmol/L) and total cholesterol:HDL ratio

    Time frame: 1 year

07

Results

Posted Jul 16, 2025

Participant flow

Participant flow — Overall Study
MilestoneDOR/3TC/TDF
Started4
Completed3
Not completed1

Outcome measures

PrimaryIdentify Number of Active Clinic Patients Who Completed the Study Protocol.

The primary objective was to determine how many clinic patients with ≥10% weight gain on an INSTI would complete the study (48 weeks).

Time frame:
1 year
Reported as:
Count of participants · Participants
Identify Number of Active Clinic Patients Who Completed the Study Protocol.
ParticipantsDOR/3TC/TDF
Identify Number of Active Clinic Patients Who Completed the Study Protocol.3
PrimaryIdentify Reasons for Study Ineligibility Among Clinic Patients on INSTI-containing Regimen Who Have Experienced Weight Gain.

Descriptive data. Reasons for study ineligibility (i.e., not meeting inclusion criteria or presence of one or more exclusion criteria) will be recorded by the study coordinator.

Time frame:
1 year
Reported as:
Count of participants · Participants
Identify Reasons for Study Ineligibility Among Clinic Patients on INSTI-containing Regimen Who Have Experienced Weight Gain.
ParticipantsDOR/3TC/TDF
started semaglutide1
did not meet weight gain threshold1
greater than 5 years INSTI use1
PrimaryIdentify Reasons for Study Refusal Among Clinic Patients on INSTI-containing Regimen Who Have Experienced Weight Gain.

Descriptive data. Clinic patients who refuse to participate in the study will be asked an open-ended question by the study coordinator about main reason(s) for declining. Responses will be grouped by the following categories: fear of side effects, distrust of researchers, general concerns about research design, interference in everyday life or changes in routine, and social discrimination.

Time frame:
1 year
Reported as:
Count of participants · Participants
Identify Reasons for Study Refusal Among Clinic Patients on INSTI-containing Regimen Who Have Experienced Weight Gain.
ParticipantsDOR/3TC/TDF
Identify Reasons for Study Refusal Among Clinic Patients on INSTI-containing Regimen Who Have Experienced Weight Gain.0
PrimaryIdentify Factors Associated With Early Study Discontinuation.

Factors will include age, gender, race, CD4 count, HIV viral load, prior enrollment in a study, history of injection drug use, and use of antidepressants.

Time frame:
1 year
Reported as:
Count of participants · Participants
Identify Factors Associated With Early Study Discontinuation.
ParticipantsDOR/3TC/TDF
study closed to futility1
completed study to week 483
SecondaryTo Determine the Change in Absolute Weight From Baseline to One Year Following the Switch to DOR/TDF/3TC.

Absolute weight (kg) at one year minus weight at baseline (kg).

Time frame:
1 year
Reported as:
Median · kg
To Determine the Change in Absolute Weight From Baseline to One Year Following the Switch to DOR/TDF/3TC.
kgDOR/3TC/TDF
To Determine the Change in Absolute Weight From Baseline to One Year Following the Switch to DOR/TDF/3TC.5.0 (0 to 7.5)
SecondaryNumber of Participants Who Experienced a Change in Weight After a Switch to DOR/TDF/3TC at 1 Year

To determine the number of participants who experienced either an increase, decrease or no change in weight (weight at 1 year vs. weight at baseline) following the switch to DOR/TDF/3TC.

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants Who Experienced a Change in Weight After a Switch to DOR/TDF/3TC at 1 Year
ParticipantsDOR/3TC/TDF
increased weight from baseline0
decreased weight from baseline2
no change in weight from baseline1
SecondaryChange in Waist Circumference From Baseline to One Year Following the Switch to DOR/TDF/3TC.

Change in waist circumference (value at 1 year minus value at baseline) will be reported. Waist circumference to be measured using a landmark just above the uppermost lateral border of the right ilium (under the participant's clothing). Measurement will be recorded to the nearest tenth of a centimeter at the end of the participant's normal expiration.

Time frame:
1 year
Reported as:
Number · cm
Change in Waist Circumference From Baseline to One Year Following the Switch to DOR/TDF/3TC.
cmDOR/3TC/TDF
participant 1-0.8
participant 2-1.1
participant 31
SecondaryNumber of Participants Who Experienced a Change in BMI Category After a Switch to DOR/TDF/3TC at One Year

Number of participants with a change in BMI category (BMI category at one year compared to BMI category at baseline) following the switch to DOR/TDF/3TC.

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants Who Experienced a Change in BMI Category After a Switch to DOR/TDF/3TC at One Year
ParticipantsDOR/3TC/TDF
moved from obese to overweight BMI1
no change in BMI category2
SecondaryNumber of Participants Who Maintain HIV RNA<50 Copies/mL After a Switch to DOR/TDF/3TC at 1 Year

To determine the number of participants who maintain viral suppression (HIV RNA \< 50 copies/ml using Abbott RealTime HIV-1 assay) at 1 year after a switch to DOR/TDF/3TC.

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants Who Maintain HIV RNA<50 Copies/mL After a Switch to DOR/TDF/3TC at 1 Year
ParticipantsDOR/3TC/TDF
Number of Participants Who Maintain HIV RNA<50 Copies/mL After a Switch to DOR/TDF/3TC at 1 Year3
SecondaryNumber of Patients With Treatment-related Adverse Events

Adverse event parameters graded according to severity: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening), Grade 5 (death) as assessed by the US DHHS NIH/NIAID Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1 (July 2017)

Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Patients With Treatment-related Adverse Events
ParticipantsDOR/3TC/TDF
Number of Patients With Treatment-related Adverse Events0
Other pre-specifiedLoss of Percentage of Total Body Fat From Baseline to One Year

loss of percentage of total body fat (difference at one year minus from baseline) following the switch from the INSTI-containing regimen to DOR/TDF/3TC according to DXA body scans.

Time frame:
1 year
Reported as:
Median · percentage change in total body fat
Loss of Percentage of Total Body Fat From Baseline to One Year
percentage change in total body fatDOR/3TC/TDF
Loss of Percentage of Total Body Fat From Baseline to One Year2.9 (1.5 to 3.5)
Other pre-specifiedChange in Self-esteem Related to Body Image as Per the Body Image Questionnaire B-WISE at One Year Versus Baseline.

The Body Weight, Image and Self-Esteem (B-WISE) questionnaire is a validated 12-item, self-administered questionnaire that assesses body image and self-esteem related to weight gain. It was selected to assess impact of weight gain/change in our study. B-WISE scores range between 12-36; higher scores are indicative of better psychosocial adjustment (12-20 = severe; 21-28 = moderate; 29-36 = mild). The change in total B-WISE scores (value at one year minus value at baseline) will be calculated.

Time frame:
1 year
Reported as:
Median · score on a scale
Change in Self-esteem Related to Body Image as Per the Body Image Questionnaire B-WISE at One Year Versus Baseline.
score on a scaleDOR/3TC/TDF
Change in Self-esteem Related to Body Image as Per the Body Image Questionnaire B-WISE at One Year Versus Baseline.5 (1 to 11)
Other pre-specifiedTo Determine the Change in Perceived Changes in Body Size as Per the FRAM Body Image Questionnaire

The change in FRAM scores (value at one year minus baseline value) will be measured.

Time frame:
1 year

Results for this outcome have not been posted.

Other pre-specifiedChange in Fasting Glucose Values Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC

The change in fasting blood glucose (value at one year minus baseline value) will be measured.

Time frame:
1 year
Reported as:
Median · mmol/L
Change in Fasting Glucose Values Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC
mmol/LDOR/3TC/TDF
Change in Fasting Glucose Values Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC-1.6 (-1.8 to -0.2)
Other pre-specifiedTo Determine the Impact From Baseline to One Year Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC on Insulin Resistance (HOMA-IR).

HOMA score: fasting plasma glucose (mmol/L) times fasting serum insulin (mU/L) divided by 22.5. A score of \<3 indicates normal insulin resistance, a score between 3 and -5 indicates moderate insulin resistance, and a score \>5 indicates severe insulin resistance.

Time frame:
1 year

Results for this outcome have not been posted.

Other pre-specifiedTo Determine the Impact From Baseline to One Year Following the Switch From the INSTI-containing Regimen to DOR/TDF/3TC on Lipid Values (Standard Lipid Panel).

Standard lipid panel includes total cholesterol, HDL, LDL, triglycerides (all mmol/L) and total cholesterol:HDL ratio

Time frame:
1 year

Results for this outcome have not been posted.

Adverse events

Collected over 48 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DOR/3TC/TDF0/3 (0%)0/3 (0%)0/3 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)DOR/3TC/TDF
<=18 years0
Between 18 and 65 years2
>=65 years1
Age, Continuous
Age, Continuous(years)DOR/3TC/TDF
Mean59 (51 to 70)
Sex: Female, Male
Sex: Female, Male(Participants)DOR/3TC/TDF
Female3
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)DOR/3TC/TDF
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)DOR/3TC/TDF
Canada3
08

Study locations

1 site
  • University Health Network
    Toronto, Ontario M5G2C4, Canada
09

References and documents

Publications

  • Lakey W, Yang LY, Yancy W, Chow SC, Hicks C. Short communication: from wasting to obesity: initial antiretroviral therapy and weight gain in HIV-infected persons. AIDS Res Hum Retroviruses. 2013 Mar;29(3):435-40. doi: 10.1089/aid.2012.0234. Epub 2012 Nov 7. PubMed 23072344 ↗
  • Kumar S, Samaras K. The Impact of Weight Gain During HIV Treatment on Risk of Pre-diabetes, Diabetes Mellitus, Cardiovascular Disease, and Mortality. Front Endocrinol (Lausanne). 2018 Nov 27;9:705. doi: 10.3389/fendo.2018.00705. eCollection 2018. PubMed 30542325 ↗
  • Venter WDF, Moorhouse M, Sokhela S, Fairlie L, Mashabane N, Masenya M, Serenata C, Akpomiemie G, Qavi A, Chandiwana N, Norris S, Chersich M, Clayden P, Abrams E, Arulappan N, Vos A, McCann K, Simmons B, Hill A. Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV. N Engl J Med. 2019 Aug 29;381(9):803-815. doi: 10.1056/NEJMoa1902824. Epub 2019 Jul 24. PubMed 31339677 ↗
  • Gomez M, Seybold U, Roider J, Harter G, Bogner JR. Correction to: A retrospective analysis of weight changes in HIV-positive patients switching from a tenofovir disoproxil fumarate (TDF)- to a tenofovir alafenamide fumarate (TAF)-containing treatment regimen in one German university hospital in 2015-2017. Infection. 2019 Feb;47(1):103-104. doi: 10.1007/s15010-018-1251-0. PubMed 30456685 ↗
  • Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/aid.2011.0275. Epub 2012 Aug 3. PubMed 22730929 ↗
  • Rockstroh JK, Lennox JL, Dejesus E, Saag MS, Lazzarin A, Wan H, Walker ML, Xu X, Zhao J, Teppler H, Dinubile MJ, Rodgers AJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK. Clin Infect Dis. 2011 Oct;53(8):807-16. doi: 10.1093/cid/cir510. PubMed 21921224 ↗
  • McCann K, Moorhouse M, Sokhela S, Venter WD, Serenata C, Qavi A, et al. Changes in DXA-assessed body composition in TAF/FTC+DTG compared to TDF/FTC+DTG and TDF/FTC/EFV in the ADVANCE clinical trial. EACS, November 6-9, 2019, Basel, Switzerland.
  • Bedimo R, Li X, Adams-Huet B, Lake J, Taylor B, Kim D, et al. Differential BMI changes following PI- and INSTI-based ART initiation by sex and race. Conference on Retroviruses and Opportunistic Infections; 2019 Mar 4-7; Seattle, Washington
  • Rebeiro P, Jenkins C, Bian A, Lake J, Bourgi K, Horberg M, et al. The effect of initiating integrase inhibitor-based vs. non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy on progression to diabetes among North American persons in HIV care. IDWeek, October 2-6, 2019, Washington, DC. Abstract LB9.
  • Schafer J, Sassa K, O'Connor J, Shimada A, Keith S, DeSimone J. BMI and ASCVD risk score changes in virologically suppressed patients with HIV switching from TDF to TAF containing ART. IDWeek, October 2-6, 2019, Washington, DC. Abstract 979
  • Kerchberger AM, Sheth AN, Angert CD, Mehta CC, Summers NA, Ofotokun I, et al. Integrase Strand Transfer Inhibitors are Associated with Weight Gain in Women. CROI, March 4-7, 2019, Seattle, DC. Abstract 672.
  • Johnson M, Kumar P, Molina JM, Rizzardini G, Cahn P, Bickel M, Mallolas J, Zhou Y, Morais C, Kumar S, Sklar P, Hanna GJ, Hwang C, Greaves W; DRIVE-SHIFT Study Group. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2019 Aug 1;81(4):463-472. doi: 10.1097/QAI.0000000000002056. PubMed 30985556 ↗
  • Hill A, Hughes SL, Gotham D, Pozniak AL. Tenofovir alafenamide versus tenofovir disoproxil fumarate: is there a true difference in efficacy and safety? J Virus Erad. 2018 Apr 1;4(2):72-79. doi: 10.1016/S2055-6640(20)30248-X. PubMed 29682298 ↗
  • Andersen JW, Fass R, van der Horst C. Factors associated with early study discontinuation in AACTG studies, DACS 200. Contemp Clin Trials. 2007 Sep;28(5):583-92. doi: 10.1016/j.cct.2007.02.002. Epub 2007 Feb 27. PubMed 17395549 ↗
  • Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed [October 30, 2019].

Study documents

  • Protocol and statistical analysis plan · Oct 19, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04665375
Lead sponsor
University Health Network, Toronto
Collaborators
Merck Canada Inc.
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Apr 26, 2021
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Results posted
Jul 16, 2025
Last update
Jul 16, 2025

Study contacts

Sharon Walmsley
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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