Body Composition Sub-study of the D2EFT Trial
- Conditions
- HIV Infections
- Interventions
- Drug: TDF 300 MG Oral TabletDrug: N(t)RTIsDrug: FTC 200 MG Oral Cap
- Registration Number
- NCT03675815
- Lead Sponsor
- Kirby Institute
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
- Fulfil the criteria for D2EFT randomisation
- Able to undergo DXA whole-body scanning
- Provide informed written consent for the D2EFT Body Composition Sub-study
- Unwilling to comply with the study requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) TDF 300 MG Oral Tablet dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd Standard of care Ritonavir 100 MG Oral Tablet darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd Standard of care N(t)RTIs darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) 3TC 300 MG Oral Tablet dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) FTC 200 MG Oral Cap dolutegravir 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 Darunavir (DRV) 800 milligram (MG) Oral Tablet dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd Dolutegravir + darunavir Ritonavir 100 MG Oral Tablet dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd Dolutegravir + darunavir Dolutegravir 50 MG Oral Tablet dolutegravir 50 mg oral tablet + darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet po qd Standard of care Darunavir (DRV) 800 milligram (MG) Oral Tablet darunavir 800 mg oral tablet + ritonavir 100 mg oral tablet + (N(t)RTIs) po qd Dolutegravir + tenofovir (TDF) + either lamivudine (3TC) or emtricitabine (FTC) Dolutegravir 50 MG Oral Tablet dolutegravir 50 mg oral tablet + TDF 300 mg oral tablet + either 3TC 300 mg oral tablet or FTC 200 mg oral capsule po qd
- Primary Outcome Measures
Name Time Method Mean/median between-group change in waist-to-hip ratio at 48 weeks umbilical waist and hip measures
Mean/median between-group change in total-to-HDL cholesterol ratio at 48 weeks total and HDL cholesterol plasma concentrations
- Secondary Outcome Measures
Name Time Method Mean/median between-group change in total-to-HDL cholesterol ratio at 96 weeks total and HDL cholesterol plasma concentrations
Mean/median between-group change in waist-to-hip ratio at 96 weeks umbilical waist and hip measures
Mean/median between-group change in body weight at week 48 and 96 body weight measurement
Mean/median between-group change in maximum umbilical and hip measures at week 48 and 96 umbilical waist and hip measures
Mean/median between-group change in fasting lipid parameters at weeks 48 and 96 total, HDL, and LDL cholesterol and triglyceride plasma concentrations
Mean/median between-group change in fasting glycaemic parameters at weeks 48 and 96 glucose, insulin, HbA1c concentrations
Mean/median between-group absolute change in limb fat assessed by DXA week 48 and 96 absolute change from baseline in limb fat
Mean/median between-group percentage change in limb fat assessed by DXA week 48 and 96 percentage change from baseline in limb fat
Mean/median between-group changes in regional body fat assessed by DXA week 48 and 96 regional = limb fat and truncal fat
Mean/median between-group changes in total body fat and lean tissue assessed by DXA week 48 and 96 total body fat and total lean tissue
Mean/median between-group changes in bone mineral content assessed by DXA week 48 and 96 total bone mineral content
Mean/median between-group change in Body Image questionnaire scores weeks 48 and 96 NIAID Adult AIDS Clinical Trials Group Baseline and Follow-up questionnaires
Proportion with Metabolic Syndrome week 0, and week 48 and 96 baseline prevalence and incidence at weeks 48 and 96
Trial Locations
- Locations (7)
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
🇿🇦Soweto, Johannesburg, South Africa
Clinical HIV Research Unit, Helen Joseph Hospital
🇿🇦Westdene, Johannesburg, South Africa
Desmond Tutu HIV Foundation
🇿🇦Cape Town, South Africa
Chennai Antiviral Research aznd Treatment (CART) Clinical Research Site
🇮🇳Chennai, India
University of Zimbabwe Clinical Research Centre
🇿🇼Harare, Zimbabwe
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross Research Centre
🇹🇭Bangkok, Thailand
Univerity of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia