An observational cohort study to evaluate the impact of the tenofovir-based single tablet regimens on adherence, quality of life and cost-effectiveness in HIV-1 infected patients (GUESS)

Study identification

• EU PAS number:
  EUPAS12725
• Study ID:
  28789
• Official title and acronym:
  An observational cohort study to evaluate the impact of the tenofovir-based single tablet regimens on adherence, quality of life and cost-effectiveness in HIV-1 infected patients (GUESS)
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  GX-PT-177-0143: The primary objective of this study was to prospectively evaluate the impact of tenofovir-based single tablet regimens (STR) on adherence in HIV-1 infected subjects.This was a multicenter, observational study with a control cohort, with retrospective and prospective follow up periods.The study duration from enrolment of the first subject to completion of the 2 years of prospective follow up of the last subject was approximately 5 years.A total of 860 adult subjects infected with HIV-1 was expected to be included in this study (400 in the STRs Cohort and 460 in the Control Cohort). However, only 476 subjects were enrolled.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hospital de Santa Maria, CHLN

Centro Hospitalar Lisboa Norte, EPE (CHLN) – Hospital Santa Maria and Hospital Pulido Valente Portugal, Centro Hospitalar do Porto, EPE (CHP) – Hospital de Santo António Portugal, Centro Hospitalar Lisboa Ocidental, EPE (CHLO) – Hospital Egas Moniz Portugal, Centro Hospitalar Universitário de Coimbra, EPE (CHUC) – Hospitais da Universidade de Coimbra Portugal, Hospital Beatriz Ângelo (HBA) Portugal, Hospital Professor Doutor Fernando Fonseca, EPE (HFF) Portugal, Hospital Garcia de Horta, EPE (HGO) Portugal, Hospital de Cascais Dr. José de Almeida Portugal, Centro Hospitalar do Baixo Vouga, EPE (CHBV) – Hospital de São Pedro Portugal, Centro Hospitalar de Vila Nova de Gaia / Espinho, EPE (CHVNGE) Portugal

Study timelines

Date when funding contract was signed

Actual:20/12/2011

Study start date

Actual:10/07/2013

Data analysis start date

Actual:30/05/2018

Date of final study report

Planned:30/09/2018

Actual:16/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable