Human Immunodeficiency Virus
Conditions
Interventions
Trade Name: TIVICAY
Product Name: Dolutegravir
Pharmaceutical Form: Tablet
INN or Proposed INN: DOLUTEGRAVIR
Other descriptive name: DOLUTEGRAVIR
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient infected with HIV-1. 2. Age> 18 years. 3. Receiving stable antiretroviral treatment for at least 3 months. 4. Current or historical treatment with 3TC or FTC. 5. Desire to change antiretroviral treatment due to intolerance or interest in simplification. 6. Undetectable viral load ( 350 cells/µL. 8. Naïve to integrase inhibitors. 9. Able to understand and give written informed consent. 10. For those included in group 1 (20 patients): no history of virological failure with an ART regimen that included 3TC or FTC or at the time of failure had a population genotype without M184V/I or K65R/E/N. 11. For those included in group 2 (20 patients): history of virological failure with TAR guideline including 3TC or FTC and historical genotype with mutations M184V/I or K65R /E/N. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N. 2. Pregnant, lactating or fertile women who do not commit to using an adequate contraceptive method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of DTG and 3TC for maintenance of virological suppression in patients with a history of treatment with 3TC or emtricitabine (FTC) (with or without M184V / I or K65R / E / N in plasma genotypes) but without presence of M184V / I or K65R / E / N mutations in proviral DNA by population sequencing.;Secondary Objective: 1. Evaluate the frequency of M184V/I or K65R/E/N mutations by NGS in HIV infected patients with suppressed viral replication. 2. Evaluate whether NGS identifies all resistance mutations previously detected in virological failure with the population resistance tests. 3. Evaluate factors related to the frequency of detection of resistance mutations in proviral DNA. 4. Analysis of the impact on the virological response of the mutations detected by NGS only. 5. Evaluate other factors related to virologic rebound during the dual therapy strategy. 6. Evaluate the impact of the dual strategy on the proviral DNA reservoir. 7. Evaluate the pharmacoeconomic impact of the dual strategy.;Primary end point(s): Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks follow-up, according to the FDA's "intention-to-treat-exposed" population snapshot algorithm. The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC.;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effectiveness: 1. Proportion of patients with viral load <50 copies/mL at week 24, according to the FDA's "intention-to-treat-exposed" population snapshot algorithm. 2. Proportion of patients with virological failure at week 48 according to the FDA snapshot algorithm. 3. Median changes in CD4 cell count/µL, relative to the baseline visit, at week 48. Safety and tolerability: 1. Incidence of adverse events and discontinuation of treatment due to toxicity or intolerance. Evaluation of the appearance of genotypic resistance mutations 1. Incidence of genotypic resistance mutations in patients with virological failure at week 48. 2. Description and frequency of genotypic resistance mutations.;Timepoint(s) of evaluation of this end point: 24 and 48 weeks | — |
Countries
Spain
Contacts
Public ContactUCICEC
Hospital Universitario La Paz
Outcome results
None listed