Dolutegravir-based Dual Therapies in HIV-infected Patients With Virological Suppression (DOLBI)
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ClinicalTrials.gov Identifier: NCT02491242
Recruitment Status :
First Posted : July 8, 2015
Last Update Posted : July 2, 2018
Asociacion para el Estudio de las Enfermedades Infecciosas
Information provided by (Responsible Party):
Jose L. Casado, Asociacion para el Estudio de las Enfermedades Infecciosas
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
Other: Dolutegravir in a dual therapy regimen
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.
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
HIV-infected patients who had initiate a dolutegravir-based dual therapy because of intolerance or toxicity to nucleoside analogues
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
Receiving other investigational drugs
Recent diagnosis of opportunistic infection (< 1 month)