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

Completed

• Conditions: HIV Infection

• Registration Number: NCT02491242
• Lead Sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas

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.

Study Timeline

• Study First Submitted: 2015-06-28
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Study Start: 2015-11
• Primary Completion: 2018-03
• Status Verified: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy	12 months	Percent of patients remaining with HIV RNA level below 50 copies/ml, according to a missing=failure criteria

Secondary Outcome Measures

Name	Time	Method
Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir	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
Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir	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).
Outcome of causes leading to switch the previous regimen	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

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain