Trial Outcomes & Findings for The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients (NCT NCT05289986)
NCT ID: NCT05289986
Last Updated: 2026-05-28
Results Overview
To quantify the effect on lipid profile (change from baseline in total fasting cholesterol to Week 24) of switching from suppressive, stable cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir to Delstrigo (TDF/3TC/DOR) in HIV positive patients.
TERMINATED
PHASE4
19 participants
24 weeks
2026-05-28
Participant Flow
19 participants were consented to the study (as per clinicaltrials.gov definition of enrolled). However, only 13 of these participants went on to be randomised into either arm delayed switch or immediate switch. Therefore, the 6 participants cannot be catagorise into this table.
Please see recruitment details.
Participant milestones
| Measure |
Immediate Switch Arm
Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
Delayed Switch Arm
Control arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks).
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
Switch
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Immediate Switch Arm
Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
Delayed Switch Arm
Control arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks).
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
|---|---|---|
|
Overall Study
Trial was terminated early
|
7
|
6
|
Baseline Characteristics
The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients
Baseline characteristics by cohort
| Measure |
Immediate Switch Arm
n=7 Participants
Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
Delayed Switch Arm
n=6 Participants
Control arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks).
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
13 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
7 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
13 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
6 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Overall Number of Baseline Participants
|
7 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
13 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
To quantify the effect on lipid profile (change from baseline in total fasting cholesterol to Week 24) of switching from suppressive, stable cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir to Delstrigo (TDF/3TC/DOR) in HIV positive patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Percentage of patients with treatment-related adverse events by week 48
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Median change in body fat content (g) measured by Total body dexa at week 24 and 48
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Body composition changes when measured by waist circumference at week 24 and 48
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
HOMA-IR is calculated by glucose \& insulin levels and provides a single unit of measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
PBMC cholesterol and cholesteryl levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Adipocytokines by assessing adiponectin, leptin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Pituitary hormones (TSH, LH, FSH, IGF-1, Testosterone)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Estimated cardiovascular risk (QRISK3 equation)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Estimated cardiovascular risk (D:A:D equation)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Hepatic steatosis and fibrosis by transient elastography-CAP (FibroScan® with the CAP probe)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Dietary preferences (using Food preference questionnaire for adolescents and adults)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Quality of Life (EuroQoL questionnaire)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Sleep quality (Pittsburgh Sleep Quality Index questionnaire)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Renal safety by uPCR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksPopulation: The study was terminated early due to a Sponsor decision and limited enrolment; therefore, participant numbers were insufficient for statistical analysis. Only two participants (one per arm) reached Week 24, the primary endpoint, preventing meaningful analysis. No participants completed the study for secondary endpoints. Although baseline data were collected for 13 participants, insufficient follow-up means these data cannot be analysed against study endpoints.
Renal safety by eGFR
Outcome measures
Outcome data not reported
Adverse Events
Immediate Switch Arm
Delayed Switch Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Switch Arm
n=7 participants at risk
Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
Delayed Switch Arm
n=6 participants at risk
Control arm (deferred switch group, N=30): Participants will continue their current triple cART regimen for 24 weeks, and then switched to taking one TDF/3TC/DOR tablet orally once daily (24 -48 weeks).
Virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period.
DELSTRIGO 100Mg-300Mg-300Mg Tablet: Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine
\- TDF/3TC/DOR)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ostopenia
|
28.6%
2/7 • Number of events 2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/7 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Eye disorders
Retinal detachment
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Toothache
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Infections and infestations
Herpes
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Surgical and medical procedures
Hair transplant
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Constipation and abdominal pain upper
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2 • 12 months
|
16.7%
1/6 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Gastrointestinal disorders
Food poisoning
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Infections and infestations
Gonorrhea
|
14.3%
1/7 • Number of events 1 • 12 months
|
0.00%
0/6 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • 12 months
|
50.0%
3/6 • Number of events 3 • 12 months
|
Additional Information
Damon Foster
Chelsea and Westminster NHS Foundation Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place