Not provided
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The CI, sponsor and funder jointly made the decision to end the trial due to lack of recruitment, as well as due to delays it was felt value of the primary endpoint had lessened to a point where its scientific value was questioned.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
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This is an open label, randomised, two-arm switch study over 48 weeks in which 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.
If patients withdraw or are withdrawn from the study treatment prematurely, an early termination visit (ETV) should occur within 30 days post withdrawal.
The hypothesis of the study is that a switch to Delstrigo, which is a combination of tenofovir disoproxil, lamivudine and doravirine (TDF/3TC/DOR) has a favourable impact on lipid metabolism, glucose, weight, body composition and hepatic steatosis.
Open-label, 2 arm, multi-centre, non-inferiority switch study.
Sample size: 60 participants
Participant population: HIV-1 infected patients on stable and suppressive triple cART.
IMP: 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)
Study setting: Patients will be identified through HIV clinic visits by their direct study medical care team and visits will be captured on a participant-screening log. A Trial Management Team will facilitate the project and liaise with participating sites in study set-up and progress.
Dose and Route of Administration:
Experimental arm (baseline visit switch group, N=30): One DOR/TDF/3TC tablet taken orally once daily for 48 weeks.
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).
Primary Objective 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.
Secondary Objectives
To investigate the effect of switch on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate switch arm | Experimental | 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. |
|
| delayed switch arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DELSTRIGO 100Mg-300Mg-300Mg Tablet | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| To Quantify the Effect on Lipid Profile | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Treatment-related Adverse Events by Week 48 | Percentage of patients with treatment-related adverse events by week 48 | 48 weeks |
| Median Change in Body Fat Content (g) Measured by Total Body Dexa at Week 24 and 48 |
Not provided
Inclusion Criteria:
HIV-1 infected, 18 years or older
On stable & suppressive triple cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir for at least 6 months
No evidence of resistance to TDF, 3TC, or DOR
No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
Women who are of childbearing potential and sexually active need to use the hormonal contraceptive methods, associated with inhibition of ovulation, listed in the protocol:
Men who are sexually active and have partners who are women of childbearing potential must be using an adequate method of contraception to avoid pregnancy (male condom or sterilisation confirmed prior to the subject's entry into the study)
Exclusion Criteria:
History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR
Concomitant medication contra-indicated with TDF, FTC or DOR
Haemoglobin <9 g/dL
Platelets <80,000/mm3
Creatinine clearance <50 mL/min
AST or ALT ≥5N
Acute Hepatitis A infection.
Concomitant DAA for anti-HCV therapy
Known acute or chronic viral hepatitis B or C.
o Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial.
Pregnant or breastfeeding women, or individuals actively trying to conceive
History of osteoporosis or bone fractures/loss
Hypersensitivity to the active substance or to any of the excipients in tenofovir disoproxil fumarate, lamivudine and/or doravirine formulations
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster Hospital NHS Foundation Trust | London | London | SW10 9NH | United Kingdom | ||
| Mortimer Market Centres |
The investigators will be provided reasonable access to statistical tables, figures, and relevant reports.
Sponsor will also provide the investigators with the full summary of the study results. The investigator is encouraged to share the summary results with the study subjects, as appropriate.
The procedures and timing for public disclosure of the results summary and for development of a manuscript for publication will be in accordance with sponsor policies.
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Please see recruitment details.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Quantify the Effect on Lipid Profile | 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. | 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. | Posted | 24 weeks |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Damon Foster | Chelsea and Westminster NHS Foundation Trust | 02033156645 | chelwest.metad@nhs.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2024 | Apr 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2023 | Sep 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Median change in body fat content (g) measured by Total body dexa at week 24 and 48
| 48 weeks |
| Body Composition Changes When Measured by Waist Circumference at Week 24 and 48 | Body composition changes when measured by waist circumference at week 24 and 48 | 48 weeks |
| Change in Insulin Sensitivity From Baseline to Week 24 and 48 by HOMA-IR (Glucose & Insulin Levels) | HOMA-IR is calculated by glucose & insulin levels and provides a single unit of measure | 48 weeks |
| PBMC Cholesterol and Cholesteryl Levels | PBMC cholesterol and cholesteryl levels | 48 weeks |
| Adipocytokines by Assessing Adiponectin, Leptin | Adipocytokines by assessing adiponectin, leptin | 48 weeks |
| Pituitary Hormones (TSH, LH, FSH, IGF-1, Testosterone) | Pituitary hormones (TSH, LH, FSH, IGF-1, Testosterone) | 48 weeks |
| Estimated Cardiovascular Risk (QRISK3 Equation) | Estimated cardiovascular risk (QRISK3 equation) | 48 weeks |
| Estimated Cardiovascular Risk (D:A:D Equation) | Estimated cardiovascular risk (D:A:D equation) | 48 weeks |
| Hepatic Steatosis and Fibrosis by Transient Elastography-CAP (FibroScan® With the CAP Probe) | Hepatic steatosis and fibrosis by transient elastography-CAP (FibroScan® with the CAP probe) | 48 weeks |
| Dietary Preferences (Using Food Preference Questionnaire for Adolescents and Adults) | Dietary preferences (using Food preference questionnaire for adolescents and adults) | 48 weeks |
| Quality of Life (EuroQoL Questionnaire) | Quality of Life (EuroQoL questionnaire) | 48 weeks |
| Sleep Quality (Pittsburgh Sleep Quality Index Questionnaire) | Sleep quality (Pittsburgh Sleep Quality Index questionnaire) | 48 weeks |
| Renal Safety by uPCR | Renal safety by uPCR | 48 weeks |
| Renal Safety by eGFR | Renal safety by eGFR | 48 weeks |
| London |
| London |
| WC1E6JB |
| United Kingdom |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Overall Number of Baseline Participants | Count of Participants | Participants |
|
| OG001 | 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) |
|
| Secondary | Percentage of Patients With Treatment-related Adverse Events by Week 48 | Percentage of patients with treatment-related adverse events by week 48 | 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. | Posted | 48 weeks |
|
|
| Secondary | Median Change in Body Fat Content (g) Measured by Total Body Dexa at Week 24 and 48 | Median change in body fat content (g) measured by Total body dexa at week 24 and 48 | 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. | Posted | 48 weeks |
|
|
| Secondary | Body Composition Changes When Measured by Waist Circumference at Week 24 and 48 | Body composition changes when measured by waist circumference at week 24 and 48 | 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. | Posted | 48 weeks |
|
|
| Secondary | Change in Insulin Sensitivity From Baseline to Week 24 and 48 by HOMA-IR (Glucose & Insulin Levels) | HOMA-IR is calculated by glucose & insulin levels and provides a single unit of measure | 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. | Posted | 48 weeks |
|
|
| Secondary | PBMC Cholesterol and Cholesteryl Levels | PBMC cholesterol and cholesteryl levels | 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. | Posted | 48 weeks |
|
|
| Secondary | Adipocytokines by Assessing Adiponectin, Leptin | Adipocytokines by assessing adiponectin, leptin | 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. | Posted | 48 weeks |
|
|
| Secondary | Pituitary Hormones (TSH, LH, FSH, IGF-1, Testosterone) | Pituitary hormones (TSH, LH, FSH, IGF-1, Testosterone) | 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. | Posted | 48 weeks |
|
|
| Secondary | Estimated Cardiovascular Risk (QRISK3 Equation) | Estimated cardiovascular risk (QRISK3 equation) | 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. | Posted | 48 weeks |
|
|
| Secondary | Estimated Cardiovascular Risk (D:A:D Equation) | Estimated cardiovascular risk (D:A:D equation) | 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. | Posted | 48 weeks |
|
|
| Secondary | Hepatic Steatosis and Fibrosis by Transient Elastography-CAP (FibroScan® With the CAP Probe) | Hepatic steatosis and fibrosis by transient elastography-CAP (FibroScan® with the CAP probe) | 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. | Posted | 48 weeks |
|
|
| Secondary | Dietary Preferences (Using Food Preference Questionnaire for Adolescents and Adults) | Dietary preferences (using Food preference questionnaire for adolescents and adults) | 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. | Posted | 48 weeks |
|
|
| Secondary | Quality of Life (EuroQoL Questionnaire) | Quality of Life (EuroQoL questionnaire) | 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. | Posted | 48 weeks |
|
|
| Secondary | Sleep Quality (Pittsburgh Sleep Quality Index Questionnaire) | Sleep quality (Pittsburgh Sleep Quality Index questionnaire) | 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. | Posted | 48 weeks |
|
|
| Secondary | Renal Safety by uPCR | Renal safety by uPCR | 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. | Posted | 48 weeks |
|
|
| Secondary | Renal Safety by eGFR | Renal safety by eGFR | 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. | Posted | 48 weeks |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | 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) | 0 | 6 | 0 | 6 | 3 | 6 |
| Hair transplant | Surgical and medical procedures | MedDRA 28.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Constipation and abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Gonorrhea | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Herpes | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Ostopenia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 28.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |