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

Asociacion para el Estudio de las Enfermedades Infecciosas

Status: Completed

Conditions: HIV Infection

Treatments: Other: Dolutegravir in a dual therapy regimen

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02491242

Dolbi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)