NCT02491242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

2.3 years

First QC Date

June 28, 2015

Last Update Submit

June 29, 2018

Conditions

HIV Infection

Keywords

HIVdolutegravirintolerancedual therapies

Outcome Measures

Primary Outcomes (1)

  • Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy

    Percent of patients remaining with HIV RNA level below 50 copies/ml, according to a missing=failure criteria

    12 months

Secondary Outcomes (3)

  • Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir

    12 months

  • Outcome of causes leading to switch the previous regimen

    12 months

  • Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir

    12 months

Other Outcomes (1)

  • Rate of virological suppression in patients with previous failure to more than 2 families of antiretroviral drugs

    12 months

Interventions

Dolutegravir in a dual therapy regimenOTHER

None. Patients initiating Dolutegravir-based dual therapy because of nucleoside analogues toxicity or intolerance will be followed up during a year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramon y Cajal Hospital

Madrid, 28034, Spain

Location

Related Publications (2)

  • Casado JL, Monsalvo M, Fontecha M, Vizcarra P, Rodriguez MA, Vivancos MJ, Moreno S. Dolutegravir plus rilpivirine as dual regimen in virologically suppressed HIV-1 infected patients in a clinical setting. HIV Res Clin Pract. 2019 Apr;20(2):64-72. doi: 10.1080/15284336.2019.1628460. Epub 2019 Jun 19.

    PMID: 31303142DERIVED

  • Vizcarra P, Fontecha M, Monsalvo M, Vivancos MJ, Rojo A, Casado JL. Efficacy and safety of dolutegravir plus boosted-darunavir dual therapy among highly treatment-experienced patients. Antivir Ther. 2019;24(6):467-471. doi: 10.3851/IMP3319.

    PMID: 31172977DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

dolutegravir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jose L Casado, MD, PhD

    Ramon y Cajal Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, MD, PhD

Study Record Dates

First Submitted

June 28, 2015

First Posted

July 8, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

ES(1)