HIV infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Triumeq
Product Name: Triumeq
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ABACAVIR SULFATE
CAS Number: 188062-50-2
Other descriptive name: ABACAVIR SULFATE
Concentration u
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult = 18 years old having a diagnosis of HIV-1 infection. 2. Current ARV therapy with Triumeq® started at least 6 months before baseline. 3. Evidence of gain weight =5% during treatment with Triumeq® not associated with any medical condition or change of habit. 4. Maintained undetectable plasma HIV-1 RNA (viral load =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Previous virological failure to protease inhibitors. 2. Suspected or documented resistance mutations to the protease, as well as NRTI–related mutations that may impact nucleoside activity. 3. Systemic concurrent process such as coinfection with hepatitis C or B, acute systemic infection within the last 4 months, neoplasm, chronic inflammatory process, or any other condition that could impair subject’s safety, according to investigator criteria. 4. Treatment with drugs or other conditions that induce an increase (corticosteroids, antidepressants and antipsychotics, stop smoking habit, etc) or decrease (amphetamine, antidiabetics, diet, etc) of body fat. 5. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess changes in weight after switching from Triumeq® to Rezolsta® plus Kivexa® or to Symtuza® in those HIV-infected people who presented weight gain during the dolutegravir-based regimen.;Secondary Objective: To assess the mechanisms of weight gain associated with dolutegravir by changes in: - Body mass index. - Total body composition measured by DEXA scan. - Waist-to-hip ratio. - Different abdominal fat layers measured by ultrasound. - Lipid and lipoprotein parameters in blood. - HOMA-IR, adiponectin and leptin. - Cytokines, and other hormonal parameters, depending on the region where abdominal fat changes are observed. To assess the safety of the switch from Triumeq® to Rezolsta® and Kivexa® or Symtuza® by changes in virological and immunological parameters and incidence of adverse events and drug-related discontinuations.;Primary end point(s): To compare the percentage of individuals with a significant reduction in weight after 48 weeks between groups (Triumeq® versus Rezolsta® and Kivexa® or Symtuza®), and intragroup. Significant reduction of weight will be defined as a decrease of =5% from study baseline weight. Thus, the following categories for grouping individuals according to the reduction in weight will be used: 10%.;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare changes between groups (Triumeqâversus Rezolstaâ plus Kivexaâ or Symtuza®) and intragroup at week 48 from baseline in: - BMI and percentage of individuals whose BMI changed from normal-overweigh- obesity or the reverse. - Total body composition assessed by DEXA scan. According to a World Health Organization expert committee, ‘‘there is no agreement about cut-off points for the percentage of body fat that constitutes obesity’’. Thus, the following categories for grouping individuals according to the changes in whole-body percentage fat will be used: 10%. - Waist-to-hip ratio - Percentage of individuals who change > 5% in whole-body percentage body fat calculated as total body fat mass divided by total mass (from DEXA) x 100. - Abdominal fat layers [superficial and profound subcutaneous fat, preperitoneal fat, visceral (omental) fat and retroperitoneal (para and perirenal) fat] measured by ultrasound. - Lipid and lipoprotein parameters. - Lumbar spine (L2-L4) and femoral (total femur, trochanter, femoral neck) bone mass density (BMD) and T-scores. - HOMA-IR, adiponectin and leptin - Cytokines, and other hormonal parameters, depending on the region where abdominal fat changes are observed. - Virological and immunological (CD4 and CD8 T cell counts) changes. - Percentage of subjects with AE and ARV drug-related discontinuations.;Timepoint(s) of evaluation of this end point: Week 48 | — |
Countries
Spain
Contacts
Public ContactFLS-Research Support
Fundació Lluita contra la SIDA
Outcome results
None listed