Tivicay (dolutegravir) / ViiV Healthcare 
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  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD)
    Journal:  Obesity Modifies the Relationship Between Raltegravir and Dolutegravir Hair Concentrations and Body Weight Gain in Women Living with HIV. (Pubmed Central) -  May 4, 2023   
    Over ~1y, women experienced median increases in body weight: 1.71% (-1.78, 5.00) with RAL; 2.40% (-2.82, 6.50) with EVG; 2.48% (-3.60, 7.88) with DTG.??Baseline obesity status modified the relationship between hair concentrations and percent weight change for DTG and RAL (p's<0.05): higher DTG, yet lower RAL concentrations were associated with greater weight gain among non-obese women. Additional pharmacologic assessments are needed to understand the role of drug exposure in INSTI-associated weight gain.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Efficacy, Convenience, Safety and Durability of DTG-Based Antiretroviral Therapies: Evidence from a Prospective Study by the Italian MaSTER Cohort. (Pubmed Central) -  May 2, 2023   
    Background: Dolutegravir (DTG) is recommended by international guidelines as a main component of an optimal initial regimen of cART (combination antiretroviral treatment) in people living with HIV (PLWH) and in case of switching for failure or optimization strategies...The results of this prospective real-life study confirm the apparent low risk of changing DTG-containing regimens due to virological failure. They may also help physicians to identify people with increased risk of interruption for different reasons, suggesting targeted medical interventions.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Combination Antiretroviral Therapy and Immunophenotype of Feline Immunodeficiency Virus. (Pubmed Central) -  May 2, 2023   
    Of the cART drugs, dolutegravir was the most stable and long-lasting. These findings provide a critical insight into novel cART formulations in FIV-infected cats and highlight their role as a potential animal model to evaluate the impact of cART on lentiviral infection and immune dysregulation.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Vemlidy (tenofovir alafenamide) / Gilead
    Biomarker, Journal:  Pharmacogenetics of tenofovir clearance among Southern Africans living with HIV. (Pubmed Central) -  Apr 30, 2023   
    P3
    Among Southern Africans randomized to TAF or TDF in ADVANCE, unexplained variability in tenofovir clearance was associated with a polymorphism in IFNL4, an immune-response gene. It is unclear how this gene would affect tenofovir disposition.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD), Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Journal:  Development of Potential Inhibitors for Human T-lymphotropic virus type I Integrase enzyme: A molecular modeling approach. (Pubmed Central) -  Apr 28, 2023   
    It is unclear how this gene would affect tenofovir disposition. Combing structure-based design and virtual screening resulted in identifying three drug-like molecules (PubChem CID_138739497, _70381610, and _140084032) that are suggested as lead compounds for developing effective drugs targeting HTLV-1 integrase enzyme.
  • ||||||||||  NN1213 / Novo Nordisk, Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial primary completion date:  DGVTAF: Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection (clinicaltrials.gov) -  Apr 28, 2023   
    P4,  N=74, Active, not recruiting, 
    In conclusion, ARVs induce mitochondrial stress and dysfunction, which may be closely associated with the progression of insulin resistance. Trial completion date: Apr 2023 --> Apr 2025 | Trial primary completion date: Apr 2023 --> Apr 2024
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Isentress (raltegravir) / Merck (MSD), Vitekta (elvitegravir) / Japan Tobacco, Gilead
    INTEGRASE INHIBITORS IN CHILDREN AND ADOLESCENTS: CLINICAL USE AND RESISTANCE (STATION 5) -  Apr 21, 2023 - Abstract #ESPID2023ESPID_722;    
    We recommend the integration of hypertension management in the HIV treatment package and policies to improve existing supply chains for low cost and high-quality hypertension medications. Overall, 318 INI-based regimens were implemented in 288 patients [53.8% female; median age at start of 14.3 years (IQR 12.0
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment open, Trial completion date, Trial primary completion date:  The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers (clinicaltrials.gov) -  Apr 20, 2023   
    P1,  N=16, Recruiting, 
    Overall, 318 INI-based regimens were implemented in 288 patients [53.8% female; median age at start of 14.3 years (IQR 12.0 Not yet recruiting --> Recruiting | Trial completion date: Jan 2022 --> Dec 2023 | Trial primary completion date: Jan 2022 --> Dec 2023
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial initiation date, Trial primary completion date:  Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis (clinicaltrials.gov) -  Apr 11, 2023   
    P2,  N=30, Not yet recruiting, 
    Figure: BLV alone (N=18) BLV + PEG-IFN (N=10) Normal ALT level (< 40 IU/L) 10 (55.6 %) 4 (44.4%) 2 log decrease from baseline or undetectable HDV-RNA (%) 11 (61.1%) 6 (60.0%) Undetectable HDV-RNA (%) 7 (38.9%) 5 (50.0%) Trial completion date: Oct 2024 --> Jan 2025 | Initiation date: Feb 2023 --> May 2023 | Trial primary completion date: Mar 2024 --> Jun 2024
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion date, Trial initiation date, Trial primary completion date:  RESOLVE: A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa (clinicaltrials.gov) -  Apr 6, 2023   
    P=N/A,  N=648, Not yet recruiting, 
    Trial completion date: Oct 2024 --> Jan 2025 | Initiation date: Feb 2023 --> May 2023 | Trial primary completion date: Mar 2024 --> Jun 2024 Trial completion date: Sep 2026 --> May 2027 | Initiation date: Aug 2022 --> Jun 2023 | Trial primary completion date: Sep 2026 --> May 2027
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment closed:  DISCO: Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa (clinicaltrials.gov) -  Apr 6, 2023   
    P=N/A,  N=1000, Active, not recruiting, 
    Trial completion date: Sep 2026 --> May 2027 | Initiation date: Aug 2022 --> Jun 2023 | Trial primary completion date: Sep 2026 --> May 2027 Recruiting --> Active, not recruiting
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Long-term outcome of dolutegravir-containing regimens according to sex: data from the ICONA study. (Pubmed Central) -  Apr 4, 2023   
    In our cohort of PLWH treated with dolutegravir-based regimens and followed up for up to 4 years, we observed a low risk of treatment failure and no evidence for a difference by sex, after excluding discontinuation due to pregnancy concerns. However, we observed a higher risk of dolutegravir discontinuation for toxicity in women.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Review, Journal:  The End Is in Sight: Current Strategies for the Elimination of HIV Vertical Transmission. (Pubmed Central) -  Mar 28, 2023   
    The proven safety and efficacy of integrase inhibitors such as dolutegravir may be particularly useful in suppressing viremia in pregnant persons who present late for ART treatment...Substantial progress has been made in recent years to eliminate HIV perinatal transmission. Future research hinges upon a multipronged approach to improving HIV detection, risk-stratified treatment strategies, and prevention of primary HIV infection among pregnant persons.
  • ||||||||||  bictegravir (GS-9883) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Weight gain in HIV-infected patients. (Pubmed Central) -  Mar 25, 2023   
    Even though different mechanisms of action have been proposed by which these agents would cause weight gain, the exact processes remain unclarified. Efforts are currently focused on knowing not only these mechanisms, but, more importantly, on finding the clinical relevance that this abnormal weight gain could have in other pathologies such as diabetes or cardiovascular events.
  • ||||||||||  Tracleer (bosentan) / J&J, Roche, Tivicay (dolutegravir) / ViiV Healthcare
    Endothelin Receptor Antagonists (ERA) and Integrase Inhibitors: Competition or Cooperation? (Walter E. Washington Convention Center, Area B, Hall C (Lower Level)) -  Mar 25, 2023 - Abstract #ATS2023ATS_6919;    
    All HIV-PAH patients who were using ERA (ambrisentan or bosentan) at our service from 2010 to 2021 were evaluated, a total of 12. Of these, data from 3 patients were excluded because they didn
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Journal:  Cohort profile: InfCareHIV, a prospective registry-based cohort study of people with diagnosed HIV in Sweden. (Pubmed Central) -  Mar 24, 2023   
    Dolutegravir-based treatment in PLHIV with pre-existing nucleoside reverse transcriptase inhibitor-mutations was non-inferior to protease inhibitor-based regimens...Self-reported sexual satisfaction in PLHIV is improving and is higher in women than men. InfCareHIV provides a unique base to study and further improve long-term treatment outcomes, comorbidity management and health-related quality of life in people with HIV in Sweden.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Trial completion, Trial completion date, Trial primary completion date:  The DTG-SWITCH Study: Longitudinal Analysis of Virologic Failure and Drug Resistance at and After Switching to Dolutegravir-based First-line ART (clinicaltrials.gov) -  Mar 23, 2023   
    P=N/A,  N=2820, Completed, 
    At W48, B/F/TAF was noninferior to DTG+F/TDF at achieving HIV-1 RNA <50 copies/mL (95% vs 91%, difference 4.1%; 95% CI -2.5% to 10.8%, p=0.21), with mean CD4 gains of +200 and +175 cells/?L, respectively. Active, not recruiting --> Completed | Trial completion date: Nov 2022 --> Mar 2023 | Trial primary completion date: Nov 2021 --> Mar 2023