HivPhase 4AVERTAS-2NCT04903847
Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil
A Phase 4 study testing Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] in people with Hiv and HIV Infections, run by Thomas Benfield at 5 sites in Denmark.
Trial summary
Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, HIV Infections, HIV Lipodystrophy
- What is being tested?
- Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 5 sitesDenmark
- Study dates
- 2 Feb 2021to 2 Feb 2023
- 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
- Individuals ≥ 18 years old with diagnosed HIV and at least 6 months of ongoing treatment with dolutegravir/ doravirin/lamivudine will be included. Patients must have a plasma viral load (HIV-RNA) < 50 copies/ml at inclusion. For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
Who cannot join
- Patients will be excluded in case of pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine the presence of hepatitis B antigen (HBsAg) or HBV DNA, cancer within past 5 years, pregnancy or breastfeeding. Any case of diabetes, cardiovascular disease or other chronic illness must be considered stable as assessed by the treating physician.
Trial locations and contacts
5 sites in 1 country.
Thomas Benfield, MD contact
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Not yet recruiting
Department of Infectious Diseases, Aalborg University Hospital
Aalborg, 9000
Henrik Nielsen, MD, DMSc
- Not yet recruiting
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, 8200
Alex L Laursen, MD, PhD
- Not yet recruiting
Department of Infectious Diseases, Rigshospitalet
Copenhagen, 2100
Jan Gerstoft, MD, DMSc
- Recruiting
Department of Infectious Diseases, Hvidovre University Hospital
Hvidovre, 2650
Karen BH Pedersen, MD, +4521623027, karen.brorup.heje.pedersen@regionh.dk
- Not yet recruiting
Department of Infectious Diseases, Odense University Hospital
Odense, 5000
Isik S Johansen, MD, DMSc
About this study
Official title: Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2
Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.
Read the detailed description
Randomized controlled parallel open-label study in persons living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.
Participants (n=126) are randomized to continue 3 drug-regimen dolutegravir/tenofovir disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine. Follow-up is 48 weeks. Data is collected at baseline and week 48.
Primary outcome is changes in weight from baseline of more than 2 kg.
Secondary outcomes are virus persistent viral suppression, changes in body composition and metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and fat infiltration.
- Conditions
- Hiv, HIV Infections, HIV Lipodystrophy, Osteoporosis, Renal Insufficiency, Weight Gain
- Being tested
- Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO], Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
- Keywords
- HIV, antiretroviral therapy, antiretroviral therapy adverse events, weight gain, body composition, fat distribution
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Osteoporosis, Renal Insufficiency, Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]Drug
Also called Dovato
Two-drug therapy
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]Drug
Also called Delstrigo
Three-drug therapy
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir/tenofovir disproxil/lamivudine | No intervention | Continue dolutegravir 50 mg, tenofovir disproxil 245 mg, ,and lamivudine 300 mg once daily for 48 weeks. |
| dolutegravir/lamivudine | Experimental | dolutegravir 50 mg/lamivudine 300 mg once daily for 48 weeks Receives: Drug: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] |
| doravirine/tenofovir disproxil/lamivudine | Experimental | 100 mg doravirin, 245 mg tenofovirdisoproxil and 300 mg lamivudine once daily for 48 weeks. Receives: Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Primary outcome is a change in body weight of more than 2 kg from
Measured: 48 Weeks
Secondary outcomes (26)
Virological control
Plasma HIV-RNA <50 copies/ml
Measured: 48 weeks
Self-rated health
Changes in 12-item Short Form Health Survey (SF-12). Scores from 0 (worse) to 100 (best).
Measured: 48 weeks
Insulin resistance
Impaired insulin resistance and/or β-cell function determined by changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: 48 weeks
Diabetic profile
Changes in HbA1c
Measured: 48 weeks
Cholesterol profile
Changes in cholesterol total, HDL, LDL, VLDL
Measured: 48 weeks
Fat distribution
Changes in Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) determined by thoracic and upper abdominal CT-scan.
Measured: 48 weeks
Hepatic elasticity
Changes in hepativ elasticity determined by liver elastography (Fibro-scan)
Measured: 48 weeks
Hepatic fat infiltration
Changes in hepatic fat infiltration determined by liver elastography (Fibro-scan) and upper abdominal CT-scan
Measured: 48 weeks
Body composition/perfiferal and central fat distribution
Changes in body fat distribtuion determined bu Dual Energy X-ray Absorbtiometry (DEXA)
Measured: 48 weeks
Estimated Glomerular Filtration Rate (eGFR) (creatinine)
Changes in eGFR estimated by plasma creatinine
Measured: 48 weeks
eGFR (cystatin)
Changes in estimated by plasma cystatin
Measured: 48 weeks
Urea
Changes in plasma urea
Measured: 48 weeks
Urine RBP/creatinine ratio
Changes in Urine RBP/creatinine ratio determined by spot urine Retinol Binding Protein (RBP) and creatinine analysis
Measured: 48 weeks
Urine Beta-2-Microglobulin(B2M)/creatinine ratio
Changes in B2M/creatinine ratio determined by spot urine B2M and creatinine
Measured: 48 weeks
Urine albumin/creatinine ratio
Changes in Urine albumin/creatinine ratio determined by spot urine albumine and creatinine analysis
Measured: 48 weeks
Urine protein/creatinine ratio
Changes in urine protein/creatinine ratio determined by spot urine protein and creatinine analysis
Measured: 48 weeks
Urine phosphate
Changes in spot urine phosphate
Measured: 48 weeks
Bone mass density (BMD)
Changes in BMD assessed by DEXA
Measured: 48 weeks
Bone-specific alkaline phosphate
Changes in plasma Bone-specific alkaline phosphate
Measured: 48 weeks
Procollagen type 1 N-pro-peptide
Changes in procollagen type 1 N-pro-peptide
Measured: 48 weeks
Type 1 collagen cross-linked C-telopeptide
Changes in plasma Type 1 collagen cross-linked C-telopeptide
Measured: 48 weeks
Osteocalcin
Changes in plasma osteocalcin
Measured: 48 weeks
Fasting ionized calcium
Changes in plasma fasting ionized calcium
Measured: 48 weeks
25(OH)vitamin D vitamin D 25(OH)vitamin D
Changes in plasma 25(OH)vitamin D
Measured: 48 weeks
Parathyroid hormone (PTH) vitamin D 25(OH)vitamin D
Changes in plasma parathyroid hormone (PTH)
Measured: 48 weeks
Inflammation
High-sensitive C-reactive protein
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start2 Feb 2021
- Primary completion2 Feb 2023 (estimated)
- Study completion2 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- Model description
- Randomized controlled open-label superiority trial
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Benfield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Benfield, Hvidovre University Hospital
- Investigators
- Thomas Benfield, MD, Study director, Center of Research and Disruption of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903847
- Sponsor's protocol ID
- H-20012194
- Acronym
- AVERTAS-2
- Status last verified
- May 2021
- First submitted
- 9 Oct 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belloso WH, Orellana LC, Grinsztejn B, Madero JS, La Rosa A, Veloso VG, Sanchez J, Ismerio Moreira R, Crabtree-Ramirez B, Garcia Messina O, Lasala MB, Peinado J, Losso MH. Analysis of serious non-AIDS events among HIV-infected adults at Latin American sites. HIV Med. 2010 Oct 1;11(9):554-64. doi: 10.1111/j.1468-1293.2010.00824.x. Epub 2010 Mar 21.
PubMed 20345879Smith CJ, Ryom L, Weber R, Morlat P, Pradier C, Reiss P, Kowalska JD, de Wit S, Law M, el Sadr W, Kirk O, Friis-Moller N, Monforte Ad, Phillips AN, Sabin CA, Lundgren JD; D:A:D Study Group. Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration. Lancet. 2014 Jul 19;384(9939):241-8. doi: 10.1016/S0140-6736(14)60604-8.
PubMed 25042234Brown TT, Cole SR, Li X, Kingsley LA, Palella FJ, Riddler SA, Visscher BR, Margolick JB, Dobs AS. Antiretroviral therapy and the prevalence and incidence of diabetes mellitus in the multicenter AIDS cohort study. Arch Intern Med. 2005 May 23;165(10):1179-84. doi: 10.1001/archinte.165.10.1179.
PubMed 15911733Koethe JR, Jenkins CA, Lau B, Shepherd BE, Justice AC, Tate JP, Buchacz K, Napravnik S, Mayor AM, Horberg MA, Blashill AJ, Willig A, Wester CW, Silverberg MJ, Gill J, Thorne JE, Klein M, Eron JJ, Kitahata MM, Sterling TR, Moore RD; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD). Rising Obesity Prevalence and Weight Gain Among Adults Starting Antiretroviral Therapy in the United States and Canada. AIDS Res Hum Retroviruses. 2016 Jan;32(1):50-8. doi: 10.1089/aid.2015.0147. Epub 2015 Sep 9.
PubMed 26352511Bakal DR, Coelho LE, Luz PM, Clark JL, De Boni RB, Cardoso SW, Veloso VG, Lake JE, Grinsztejn B. Obesity following ART initiation is common and influenced by both traditional and HIV-/ART-specific risk factors. J Antimicrob Chemother. 2018 Aug 1;73(8):2177-2185. doi: 10.1093/jac/dky145.
PubMed 29722811Hill A, Waters L, Pozniak A. Are new antiretroviral treatments increasing the risks of clinical obesity? J Virus Erad. 2019 Jan 1;5(1):41-43. doi: 10.1016/S2055-6640(20)30277-6.
PubMed 30800425Sax PE, Erlandson KM, Lake JE, Mccomsey GA, Orkin C, Esser S, Brown TT, Rockstroh JK, Wei X, Carter CC, Zhong L, Brainard DM, Melbourne K, Das M, Stellbrink HJ, Post FA, Waters L, Koethe JR. Weight Gain Following Initiation of Antiretroviral Therapy: Risk Factors in Randomized Comparative Clinical Trials. Clin Infect Dis. 2020 Sep 12;71(6):1379-1389. doi: 10.1093/cid/ciz999.
PubMed 31606734Burns JE, Stirrup OT, Dunn D, Runcie-Unger I, Milinkovic A, Candfield S, Lukha H, Severn A, Waters L, Edwards S, Gilson R, Pett SL. No overall change in the rate of weight gain after switching to an integrase-inhibitor in virologically suppressed adults with HIV. AIDS. 2020 Jan 1;34(1):109-114. doi: 10.1097/QAD.0000000000002379.
PubMed 31567162Vizcarra P, Vivancos MJ, Perez-Elias MJ, Moreno A, Casado JL. Weight gain in people living with HIV switched to dual therapy: changes in body fat mass. AIDS. 2020 Jan 1;34(1):155-157. doi: 10.1097/QAD.0000000000002421.
PubMed 31714355Nartey ET, Tetteh RA, Yankey BA, Mantel-Teeuwisse AK, Leufkens HGM, Dodoo ANO, Lartey M. Tenofovir-associated renal toxicity in a cohort of HIV infected patients in Ghana. BMC Res Notes. 2019 Jul 22;12(1):445. doi: 10.1186/s13104-019-4454-2.
PubMed 31331365Nishijima T, Kawasaki Y, Tanaka N, Mizushima D, Aoki T, Watanabe K, Kinai E, Honda H, Yazaki H, Tanuma J, Tsukada K, Teruya K, Kikuchi Y, Gatanaga H, Oka S. Long-term exposure to tenofovir continuously decrease renal function in HIV-1-infected patients with low body weight: results from 10 years of follow-up. AIDS. 2014 Aug 24;28(13):1903-10. doi: 10.1097/QAD.0000000000000347.
PubMed 25259702Casado JL, Santiuste C, Vazquez M, Banon S, Rosillo M, Gomez A, Perez-Elias MJ, Caballero C, Rey JM, Moreno S. Bone mineral density decline according to renal tubular dysfunction and phosphaturia in tenofovir-exposed HIV-infected patients. AIDS. 2016 Jun 1;30(9):1423-31. doi: 10.1097/QAD.0000000000001067.
PubMed 26919733Gupta SK, Yeh E, Kitch DW, Brown TT, Venuto CS, Morse GD, Ha B, Melbourne K, McComsey GA. Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother. 2017 Jul 1;72(7):2042-2048. doi: 10.1093/jac/dkx076.
PubMed 28369419Jacobson DL, Spiegelman D, Knox TK, Wilson IB. Evolution and predictors of change in total bone mineral density over time in HIV-infected men and women in the nutrition for healthy living study. J Acquir Immune Defic Syndr. 2008 Nov 1;49(3):298-308. doi: 10.1097/QAI.0b013e3181893e8e.
PubMed 18845956
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2
- ClinicalTrials.gov ID
- NCT04903847
- Acronym / sponsor ID
- AVERTAS-2 / H-20012194
- Conditions
- Hiv, HIV Infections, HIV Lipodystrophy, Osteoporosis, Renal Insufficiency, Weight Gain
- Keywords
- HIV, antiretroviral therapy, antiretroviral therapy adverse events, weight gain, body composition, fat distribution
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Thomas BenfieldUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 2 Feb 2023 (estimated)
- Study completion
- 2 Feb 2023 (estimated)
- First posted
- 27 May 2021 (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.
Randomized controlled parallel open-label study in persons living with HIV. The aim is to study weight changes in patients switching from a dolutegravir and tenofovir disoproxil containing regimen to either a dolutegravir or tenofovir disoproxil free regimen.
Detailed description
Randomized controlled parallel open-label study in persons living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion.
Participants (n=126) are randomized to continue 3 drug-regimen dolutegravir/tenofovir disoproxil/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention 1) or to three-drug regimen with doravirine/tenofovir disoproxil/lamivudine. Follow-up is 48 weeks. Data is collected at baseline and week 48.
Primary outcome is changes in weight from baseline of more than 2 kg.
Secondary outcomes are virus persistent viral suppression, changes in body composition and metabolism, changes in bone metabolisme and renal function, changes in liver elasticity and fat infiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled open-label superiority trial
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir/tenofovir disproxil/lamivudine | No intervention | –Continue dolutegravir 50 mg, tenofovir disproxil 245 mg, ,and lamivudine 300 mg once daily for 48 weeks. |
| dolutegravir/lamivudine | Experimental | Drug: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]dolutegravir 50 mg/lamivudine 300 mg once daily for 48 weeks |
| doravirine/tenofovir disproxil/lamivudine | Experimental | Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]100 mg doravirin, 245 mg tenofovirdisoproxil and 300 mg lamivudine once daily for 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals ≥ 18 years old with diagnosed HIV and at least 6 months of ongoing treatment with dolutegravir/ doravirin/lamivudine will be included. Patients must have a plasma viral load (HIV-RNA) < 50 copies/ml at inclusion. For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
Key exclusion criteria (1 listed)
- Patients will be excluded in case of pre-existing viral resistance mutations to lamivudine, dolutegravir, tenofovir or doravirine the presence of hepatitis B antigen (HBsAg) or HBV DNA, cancer within past 5 years, pregnancy or breastfeeding. Any case of diabetes, cardiovascular disease or other chronic illness must be considered stable as assessed by the treating physician.
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 |
|---|---|---|
| Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]Also: DovatoTwo-drug therapy | Drug | dolutegravir/lamivudine |
| Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]Also: DelstrigoThree-drug therapy | Drug | doravirine/tenofovir disproxil/lamivudine |
Primary outcome
Body weight
Time frame: 48 Weeks
Primary outcome is a change in body weight of more than 2 kg from
26 secondary outcomes
Virological control
Time frame: 48 weeks
Self-rated health
Time frame: 48 weeks
Insulin resistance
Time frame: 48 weeks
Diabetic profile
Time frame: 48 weeks
Cholesterol profile
Time frame: 48 weeks
Fat distribution
Time frame: 48 weeks
Hepatic elasticity
Time frame: 48 weeks
Hepatic fat infiltration
Time frame: 48 weeks
Body composition/perfiferal and central fat distribution
Time frame: 48 weeks
Estimated Glomerular Filtration Rate (eGFR) (creatinine)
Time frame: 48 weeks
eGFR (cystatin)
Time frame: 48 weeks
Urea
Time frame: 48 weeks
Urine RBP/creatinine ratio
Time frame: 48 weeks
Urine Beta-2-Microglobulin(B2M)/creatinine ratio
Time frame: 48 weeks
Urine albumin/creatinine ratio
Time frame: 48 weeks
Urine protein/creatinine ratio
Time frame: 48 weeks
Urine phosphate
Time frame: 48 weeks
Bone mass density (BMD)
Time frame: 48 weeks
Bone-specific alkaline phosphate
Time frame: 48 weeks
Procollagen type 1 N-pro-peptide
Time frame: 48 weeks
Type 1 collagen cross-linked C-telopeptide
Time frame: 48 weeks
Osteocalcin
Time frame: 48 weeks
Fasting ionized calcium
Time frame: 48 weeks
25(OH)vitamin D vitamin D 25(OH)vitamin D
Time frame: 48 weeks
Parathyroid hormone (PTH) vitamin D 25(OH)vitamin D
Time frame: 48 weeks
Inflammation
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Background: PubMed 20345879Belloso WH, Orellana LC, Grinsztejn B, Madero JS, La Rosa A, Veloso VG, Sanchez J, Ismerio Moreira R, Crabtree-Ramirez B, Garcia Messina O, Lasala MB, Peinado J, Losso MH. Analysis of serious non-AIDS events among HIV-infected adults at Latin American sites. HIV Med. 2010 Oct 1;11(9):554-64. doi: 10.1111/j.1468-1293.2010.00824.x. Epub 2010 Mar 21.
- Background: PubMed 25042234Smith CJ, Ryom L, Weber R, Morlat P, Pradier C, Reiss P, Kowalska JD, de Wit S, Law M, el Sadr W, Kirk O, Friis-Moller N, Monforte Ad, Phillips AN, Sabin CA, Lundgren JD; D:A:D Study Group. Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration. Lancet. 2014 Jul 19;384(9939):241-8. doi: 10.1016/S0140-6736(14)60604-8.
- Background: PubMed 15911733Brown TT, Cole SR, Li X, Kingsley LA, Palella FJ, Riddler SA, Visscher BR, Margolick JB, Dobs AS. Antiretroviral therapy and the prevalence and incidence of diabetes mellitus in the multicenter AIDS cohort study. Arch Intern Med. 2005 May 23;165(10):1179-84. doi: 10.1001/archinte.165.10.1179.
- Background: PubMed 26352511Koethe JR, Jenkins CA, Lau B, Shepherd BE, Justice AC, Tate JP, Buchacz K, Napravnik S, Mayor AM, Horberg MA, Blashill AJ, Willig A, Wester CW, Silverberg MJ, Gill J, Thorne JE, Klein M, Eron JJ, Kitahata MM, Sterling TR, Moore RD; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD). Rising Obesity Prevalence and Weight Gain Among Adults Starting Antiretroviral Therapy in the United States and Canada. AIDS Res Hum Retroviruses. 2016 Jan;32(1):50-8. doi: 10.1089/aid.2015.0147. Epub 2015 Sep 9.
- Background: PubMed 29722811Bakal DR, Coelho LE, Luz PM, Clark JL, De Boni RB, Cardoso SW, Veloso VG, Lake JE, Grinsztejn B. Obesity following ART initiation is common and influenced by both traditional and HIV-/ART-specific risk factors. J Antimicrob Chemother. 2018 Aug 1;73(8):2177-2185. doi: 10.1093/jac/dky145.
- Background: PubMed 30800425Hill A, Waters L, Pozniak A. Are new antiretroviral treatments increasing the risks of clinical obesity? J Virus Erad. 2019 Jan 1;5(1):41-43. doi: 10.1016/S2055-6640(20)30277-6.
- Background: PubMed 31606734Sax PE, Erlandson KM, Lake JE, Mccomsey GA, Orkin C, Esser S, Brown TT, Rockstroh JK, Wei X, Carter CC, Zhong L, Brainard DM, Melbourne K, Das M, Stellbrink HJ, Post FA, Waters L, Koethe JR. Weight Gain Following Initiation of Antiretroviral Therapy: Risk Factors in Randomized Comparative Clinical Trials. Clin Infect Dis. 2020 Sep 12;71(6):1379-1389. doi: 10.1093/cid/ciz999.
- Background: PubMed 31567162Burns JE, Stirrup OT, Dunn D, Runcie-Unger I, Milinkovic A, Candfield S, Lukha H, Severn A, Waters L, Edwards S, Gilson R, Pett SL. No overall change in the rate of weight gain after switching to an integrase-inhibitor in virologically suppressed adults with HIV. AIDS. 2020 Jan 1;34(1):109-114. doi: 10.1097/QAD.0000000000002379.
- Background: PubMed 31714355Vizcarra P, Vivancos MJ, Perez-Elias MJ, Moreno A, Casado JL. Weight gain in people living with HIV switched to dual therapy: changes in body fat mass. AIDS. 2020 Jan 1;34(1):155-157. doi: 10.1097/QAD.0000000000002421.
- Background: PubMed 31331365Nartey ET, Tetteh RA, Yankey BA, Mantel-Teeuwisse AK, Leufkens HGM, Dodoo ANO, Lartey M. Tenofovir-associated renal toxicity in a cohort of HIV infected patients in Ghana. BMC Res Notes. 2019 Jul 22;12(1):445. doi: 10.1186/s13104-019-4454-2.
- Background: PubMed 25259702Nishijima T, Kawasaki Y, Tanaka N, Mizushima D, Aoki T, Watanabe K, Kinai E, Honda H, Yazaki H, Tanuma J, Tsukada K, Teruya K, Kikuchi Y, Gatanaga H, Oka S. Long-term exposure to tenofovir continuously decrease renal function in HIV-1-infected patients with low body weight: results from 10 years of follow-up. AIDS. 2014 Aug 24;28(13):1903-10. doi: 10.1097/QAD.0000000000000347.
- Background: PubMed 26919733Casado JL, Santiuste C, Vazquez M, Banon S, Rosillo M, Gomez A, Perez-Elias MJ, Caballero C, Rey JM, Moreno S. Bone mineral density decline according to renal tubular dysfunction and phosphaturia in tenofovir-exposed HIV-infected patients. AIDS. 2016 Jun 1;30(9):1423-31. doi: 10.1097/QAD.0000000000001067.
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PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
Thomas Benfield, MD contact
Thomas Benfield, MD study director
Center of Research and Disruption of Infectious Diseases
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] in people with Hiv and HIV Infections, run by Thomas Benfield at 5 sites in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen BH Pedersen, MD (+4521623027, karen.brorup.heje.pedersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903847, which also lists 14 linked publications.
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 27 May 2021.