Clinical trial NCT02491242: Dolutegravir-based Dual Therapies in HIV-infected Patients With Virological Suppression
Official title: The Efficacy and Safety of Dolutegravir-based Dual Therapies in HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
dolutegravir
intolerance
dual therapies
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2015-07-08
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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)

Primary outcomes:
measure: Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy
timeFrame: 12 months
Secondary outcomes:
measure: Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir
timeFrame: 12 months
measure: Outcome of causes leading to switch the previous regimen
timeFrame: 12 months
measure: Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir
timeFrame: 12 months
Other outcomes:
measure: Rate of virological suppression in patients with previous failure to more than 2 families of antiretroviral drugs
timeFrame: 12 months
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
Study officials:
affiliation: Ramon y Cajal Hospital
name: Jose L Casado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.