HIV InfectionsPhase 4NCT03675815
Body Composition Sub-study of the D2EFT Trial
A Phase 4 study testing Darunavir (DRV) 800 milligram (MG) Oral Tablet, Ritonavir 100 MG Oral Tablet and N(t)RTIs in people with HIV Infections, run by Kirby Institute at 7 sites in 5 countries.
Trial summary
This is a non-randomised, controlled, parallel group, sub-study of D2EFT (NCT03017872), a randomised, open-label study in approximately 1,000 HIV-infected adults failing first-line antiretroviral therapy (ART) in low-middle income countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Darunavir (DRV) 800 milligram (MG) Oral Tablet, Ritonavir 100 MG Oral Tablet and N(t)RTIs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 5 Dec 2019to 15 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfil the criteria for D2EFT randomisation
- Able to undergo DXA whole-body scanning
- Provide informed written consent for the D2EFT Body Composition Sub-study
Who cannot join
- Unwilling to comply with the study requirements
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
South Africa3 sites
Desmond Tutu HIV Foundation
Cape Town, 9725
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Soweto, Johannesburg, 2013
Clinical HIV Research Unit, Helen Joseph Hospital
Westdene, Johannesburg
India1 site
Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site
Chennai, 600113
Thailand1 site
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre
Bangkok, 10330
About this study
This is a non-randomised, controlled, parallel group, sub-study of D2EFT (NCT03017872), a randomised, open-label study in approximately 1,000 HIV-infected adults failing first-line antiretroviral therapy (ART) in low-middle income countries. The sub-study will be offered to all D2EFT sites with access to DXA technology for whole-body composition analysis. Sites will offer the sub-study to consecutive clinic patients. Patients must be approached for participation and provide informed written consent prior to randomisation into D2EFT. This study will recruit approximately 300 patients. Allocation to one of three ART treatment regimens will follow the result of D2EFT randomisation. The study will investigate the role of contemporary ART on body composition and metabolic parameters by comparing over 96 weeks the effects of the D2EFT ART regimens. The primary endpoint will be assessed at week 48.
Read the detailed description
Consenting participants will be randomised within the main D2EFT protocol to receive either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. Enrolment into the sub-study is voluntary and not a requirement for enrolment into D2EFT. Parameters relevant to this study including demographics, arm of randomised ART, smoking status, body habitus and fasting lipid parameters and resting blood pressure at required time points will be collected as part of the main D2EFT study. Sub-study specific assessments performed at baseline and at weeks 48 and 96 include clinical and laboratory assessments, sample collection and dual-energy X-ray absorptiometry (DXA)-assessed whole-body composition. Consenting participants will have blood for storage collected at weeks 0, 48 and 96. The specimens will be used for future studies into treatment of HIV infection and immunity.
- Conditions
- HIV Infections
- Being tested
- Darunavir (DRV) 800 milligram (MG) Oral Tablet, Ritonavir 100 MG Oral Tablet, N(t)RTIs, Dolutegravir 50 MG Oral Tablet, TDF 300 MG Oral Tablet
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darunavir (DRV) 800 milligram (MG) Oral TabletDrug
Also called Prezista
800 milligrams (mg) orally once daily for 96 weeks
Ritonavir 100 MG Oral TabletDrug
Also called Norvir, RTV
100 mg orally once daily for 96 weeks
N(t)RTIsDrug
Also called Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs]
Choice of N(t)RTIs determined by clinician guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection
Dolutegravir 50 MG Oral TabletDrug
Also called Tivicay, DTG
50 mg orally once daily for 96 weeks
TDF 300 MG Oral TabletDrug
Also called tenofovir disoproxil fumarate, Viread
300 mg orally once daily for 96 weeks
3TC 300 MG Oral TabletDrug
Also called lamivudine
300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician
FTC 200 MG Oral CapDrug
Also called Emtriva, emtricitabine
200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd Receives: Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet; Drug: Ritonavir 100 MG Oral Tablet; Drug: N(t)RTIs |
| Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) | Experimental | dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd Receives: Drug: Dolutegravir 50 MG Oral Tablet; Drug: TDF 300 MG Oral Tablet; Drug: 3TC 300 MG Oral Tablet; Drug: FTC 200 MG Oral Cap |
| Dolutegravir + darunavir | Experimental | dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd Receives: Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet; Drug: Ritonavir 100 MG Oral Tablet; Drug: Dolutegravir 50 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean/median between-group change in waist-to-hip ratio
umbilical waist and hip measures
Measured: at 48 weeks
Mean/median between-group change in total-to-HDL cholesterol ratio
total and HDL cholesterol plasma concentrations
Measured: at 48 weeks
Secondary outcomes (13)
Mean/median between-group change in total-to-HDL cholesterol ratio
total and HDL cholesterol plasma concentrations
Measured: at 96 weeks
Mean/median between-group change in waist-to-hip ratio
umbilical waist and hip measures
Measured: at 96 weeks
Mean/median between-group change in body weight
body weight measurement
Measured: at week 48 and 96
Mean/median between-group change in maximum umbilical and hip measures
umbilical waist and hip measures
Measured: at week 48 and 96
Mean/median between-group change in fasting lipid parameters
total, HDL, and LDL cholesterol and triglyceride plasma concentrations
Measured: at weeks 48 and 96
Mean/median between-group change in fasting glycaemic parameters
glucose, insulin, HbA1c concentrations
Measured: at weeks 48 and 96
Mean/median between-group absolute change in limb fat assessed by DXA
absolute change from baseline in limb fat
Measured: week 48 and 96
Mean/median between-group percentage change in limb fat assessed by DXA
percentage change from baseline in limb fat
Measured: week 48 and 96
Mean/median between-group changes in regional body fat assessed by DXA
regional = limb fat and truncal fat
Measured: week 48 and 96
Mean/median between-group changes in total body fat and lean tissue assessed by DXA
total body fat and total lean tissue
Measured: week 48 and 96
Mean/median between-group changes in bone mineral content assessed by DXA
total bone mineral content
Measured: week 48 and 96
Mean/median between-group change in Body Image questionnaire scores
NIAID Adult AIDS Clinical Trials Group Baseline and Follow-up questionnaires
Measured: weeks 48 and 96
Proportion with Metabolic Syndrome
baseline prevalence and incidence at weeks 48 and 96
Measured: week 0, and week 48 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start5 Dec 2019
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, MBBCh, Principal investigator, The Kirby Institute, UNSW Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675815
- Sponsor's protocol ID
- D2EFT BodyComp
- Status last verified
- Jan 2025
- First submitted
- 2 Jul 2018
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Sub-study of the D2EFT Trial
- ClinicalTrials.gov ID
- NCT03675815
- Acronym / sponsor ID
- D2EFT BodyComp
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomised, controlled, parallel group, sub-study of D2EFT (NCT03017872), a randomised, open-label study in approximately 1,000 HIV-infected adults failing first-line antiretroviral therapy (ART) in low-middle income countries. The sub-study will be offered to all D2EFT sites with access to DXA technology for whole-body composition analysis. Sites will offer the sub-study to consecutive clinic patients. Patients must be approached for participation and provide informed written consent prior to randomisation into D2EFT. This study will recruit approximately 300 patients. Allocation to one of three ART treatment regimens will follow the result of D2EFT randomisation. The study will investigate the role of contemporary ART on body composition and metabolic parameters by comparing over 96 weeks the effects of the D2EFT ART regimens. The primary endpoint will be assessed at week 48.
Detailed description
Consenting participants will be randomised within the main D2EFT protocol to receive either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. Enrolment into the sub-study is voluntary and not a requirement for enrolment into D2EFT. Parameters relevant to this study including demographics, arm of randomised ART, smoking status, body habitus and fasting lipid parameters and resting blood pressure at required time points will be collected as part of the main D2EFT study. Sub-study specific assessments performed at baseline and at weeks 48 and 96 include clinical and laboratory assessments, sample collection and dual-energy X-ray absorptiometry (DXA)-assessed whole-body composition. Consenting participants will have blood for storage collected at weeks 0, 48 and 96. The specimens will be used for future studies into treatment of HIV infection and immunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet, Drug: Ritonavir 100 MG Oral Tablet, Drug: N(t)RTIsdarunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd |
| Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) | Experimental | Drug: Dolutegravir 50 MG Oral Tablet, Drug: TDF 300 MG Oral Tablet, Drug: 3TC 300 MG Oral Tablet, Drug: FTC 200 MG Oral Capdolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd |
| Dolutegravir + darunavir | Experimental | Drug: Darunavir (DRV) 800 milligram (MG) Oral Tablet, Drug: Ritonavir 100 MG Oral Tablet, Drug: Dolutegravir 50 MG Oral Tabletdolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fulfil the criteria for D2EFT randomisation
- Able to undergo DXA whole-body scanning
- Provide informed written consent for the D2EFT Body Composition Sub-study
Key exclusion criteria (1 listed)
- Unwilling to comply with the study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darunavir (DRV) 800 milligram (MG) Oral TabletAlso: Prezista800 milligrams (mg) orally once daily for 96 weeks | Drug | Dolutegravir + darunavir, Standard of care |
| Ritonavir 100 MG Oral TabletAlso: Norvir, RTV100 mg orally once daily for 96 weeks | Drug | Dolutegravir + darunavir, Standard of care |
| N(t)RTIsAlso: Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs]Choice of N(t)RTIs determined by clinician guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection | Drug | Standard of care |
| Dolutegravir 50 MG Oral TabletAlso: Tivicay, DTG50 mg orally once daily for 96 weeks | Drug | Dolutegravir + darunavir, Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) |
| TDF 300 MG Oral TabletAlso: tenofovir disoproxil fumarate, Viread300 mg orally once daily for 96 weeks | Drug | Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) |
| 3TC 300 MG Oral TabletAlso: lamivudine300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician | Drug | Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) |
| FTC 200 MG Oral CapAlso: Emtriva, emtricitabine200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician | Drug | Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) |
Primary outcome
Mean/median between-group change in waist-to-hip ratio
Time frame: at 48 weeks
umbilical waist and hip measures
Mean/median between-group change in total-to-HDL cholesterol ratio
Time frame: at 48 weeks
total and HDL cholesterol plasma concentrations
13 secondary outcomes
Mean/median between-group change in total-to-HDL cholesterol ratio
Time frame: at 96 weeks
Mean/median between-group change in waist-to-hip ratio
Time frame: at 96 weeks
Mean/median between-group change in body weight
Time frame: at week 48 and 96
Mean/median between-group change in maximum umbilical and hip measures
Time frame: at week 48 and 96
Mean/median between-group change in fasting lipid parameters
Time frame: at weeks 48 and 96
Mean/median between-group change in fasting glycaemic parameters
Time frame: at weeks 48 and 96
Mean/median between-group absolute change in limb fat assessed by DXA
Time frame: week 48 and 96
Mean/median between-group percentage change in limb fat assessed by DXA
Time frame: week 48 and 96
Mean/median between-group changes in regional body fat assessed by DXA
Time frame: week 48 and 96
Mean/median between-group changes in total body fat and lean tissue assessed by DXA
Time frame: week 48 and 96
Mean/median between-group changes in bone mineral content assessed by DXA
Time frame: week 48 and 96
Mean/median between-group change in Body Image questionnaire scores
Time frame: weeks 48 and 96
Proportion with Metabolic Syndrome
Time frame: week 0, and week 48 and 96
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Matthews, MBBCh principal investigator
The Kirby Institute, UNSW Sydney
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darunavir (DRV) 800 milligram (MG) Oral Tablet, Ritonavir 100 MG Oral Tablet and N(t)RTIs in people with HIV Infections, run by Kirby Institute at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa, India, Malaysia, Thailand, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean/median between-group change in waist-to-hip ratio (time frame: at 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.