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

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ClinicalTrials.gov Identifier: NCT02491242
Recruitment Status : Recruiting
First Posted : July 8, 2015
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas

Study Description
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Brief Summary:
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 or disease Intervention/treatment
HIV Infection Other: Dolutegravir in a dual therapy regimen

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Efficacy and Safety of Dolutegravir-based Dual Therapies in HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues
Study Start Date : November 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Intervention Details:
  • Other: Dolutegravir in a dual therapy regimen
    None. Patients initiating Dolutegravir-based dual therapy because of nucleoside analogues toxicity or intolerance will be followed up during a year

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Dolutegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents