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

HIV Infection Clinical Trial

— DOLBI  

Official title:

The Efficacy and Safety of Dolutegravir-based Dual Therapies in HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491242
• Other study ID #: Dolbi
• Status: Completed
• Start date: November 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Asociacion para el Estudio de las Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion para el Estudio de las Enfermedades Infecciosas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of virological suppression in patients with previous failure to more than 2 families of antiretroviral drugs	Effect of extended previous failure, or mutations in the transcriptase and protease gene, in the rate of virological suppression in dolutegravir-based dual therapies	12 months
Primary	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	Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir	To collect adverse events (according to DAIDS grade events, 2009) and rate of discontinuation related with adverse events, of dual therapy after switching	12 months
Secondary	Outcome of causes leading to switch the previous regimen	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	12 months
Secondary	Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir	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).	12 months