skip to content

Clinical Trials

MainTitle

Dolutegravir-based Dual Therapies in HIV-infected Patients With Virological Suppression (DOLBI)

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2017 by Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas

Sponsor
Asociacion para el Estudio de las Enfermedades Infecciosas


Information provided by (Responsible Party)
Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas

ClinicalTrials.gov Identifier
NCT02491242

First received: June 28, 2015
Last updated: January 26, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

The objective of this study was to evaluate the efficacy and safety, and evolution of causes leading to change, of dual therapies based in Dolutegravir in patients requiring a change of virologically effective antiretroviral therapy.

Condition Intervention
HIV Infection

Other : Dolutegravir in a dual therapy regimen

Study Type: Observational [Patient Registry]
Study Design:
Official Title: The Efficacy and Safety of Dolutegravir-based Dual Therapies in HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues

Further study details as provided by Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas:

Primary Outcome Measures

  • Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy [ Time Frame: 12 months ]
    Percent of patients remaining with HIV RNA level below 50 copies/ml, according to a missing=failure criteria
Secondary Outcome Measures:
  • Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir [ Time Frame: 12 months ]
    To collect adverse events (according to DAIDS grade events, 2009) and rate of discontinuation related with adverse events, of dual therapy after switching
  • Outcome of causes leading to switch the previous regimen [ Time Frame: 12 months ]
    Evolution of causes de change: glomerular filtration rate during evolution, tubular dysfunction (proteinuria, phosphaturia, glycosuria, uricosuria),bone mineral density by DXA (dual X-ray absorptiometry), lipid disorders, adherence
  • Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir [ Time Frame: 12 months ]
    Comparison of efficacy (HIV RNA level < 50 c/ml) of the different dolutegravir-based dual therapies, according to accompanying drug (non nucleoside, especially rilpivirine), protease inhibitors (darunavir boosted with ritonavir or cobicistat), or nucleoside analogues (lamivudine).
Other Outcome Measures:
  • Rate of virological suppression in patients with previous failure to more than 2 families of antiretroviral drugs [ Time Frame: 12 months ]
    Effect of extended previous failure, or mutations in the transcriptase and protease gene, in the rate of virological suppression in dolutegravir-based dual therapies

Estimated Enrollment: 100
Study Start Date: November 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Detailed Description:

Despite the high rate of virological suppression and low risk of toxicity, HIV-infected patients continue to need new antiretroviral strategies, such as dual therapies, because of different end-organ involvement (kidney, bone, cardiovascular..), intolerance or toxicity. To date, only a protease inhibitor (PI)-based regimen was able to permit the use of dual therapies (two antiretrovirals), especially in case of patients with history of virological failure to other regimens. However, the recent license of Dolutegravir, a integrase inhibitor with high genetic barrier, could help to clinicians to manage patients with intolerance or toxicity to nucleoside analogues without putting in risk virological suppression.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

HIV-infected patients who had initiate a dolutegravir-based dual therapy because of intolerance or toxicity to nucleoside analogues

Criteria

Inclusion Criteria:

  • Older than 18 years
  • Receiving a virologically effective antiretroviral regimen
  • Switching to a dual therapy based in dolutegravir because of intolerance or toxicity to nucleoside analogues


Exclusion Criteria:
  • Pregnant women
  • Receiving other investigational drugs
  • Recent diagnosis of opportunistic infection (< 1 month)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02491242

Contacts

Contact:   Jose L Casado, MD, PhD 34913368672 jcasado.hrc@salud.madrid.org

Locations

Spain
Ramon y Cajal Hospital Recruiting
Madrid, Spain, 28034
Contact: Jose L Casado, MD, PhD    34913368672    jcasado.hrc@salud.madrid.org
Sub-Investigator: Sara Bañón, MD
Sub-Investigator: Alberto Diaz de Santiago, MD PhD
Sub-Investigator: Ana Moreno, MD PhD
Sub-Investigator: Santiago Moreno, Md PhD

Sponsors and Collaborators

Asociacion para el Estudio de las Enfermedades Infecciosas

Investigators

Principal Investigator: Jose L Casado, MD, PhD Ramon y Cajal Hospital
More Information

More Information


Responsible Party: Jose L. Casado, Physician, MD, PhD, Asociacion para el Estudio de las Enfermedades Infecciosas  
ClinicalTrials.gov Identifier: NCT02491242   History of Changes  
Other Study ID Numbers: Dolbi  
Study First Received: June 28, 2015  
Last Updated: January 26, 2017  
Individual Participant Data    
Plan to Share IPD: Undecided  

Keywords provided by Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas:

HIV
dolutegravir
intolerance
dual therapies

Additional relevant MeSH terms:
HIV Infections
Dolutegravir

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.