Quality of life viral and Immunological dynamics in patients with effectively suppressed HIV who switch second or furtherline cART to a Once daily High genetic barrier Antiretroviral regimen of boosted darunavir and dolutegravir
Withdrawn
- Conditions
- hiv1002146010047438
- Registration Number
- NL-OMON41798
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
- 18 years or older
- Switch on clinical grounds to dolutegravir/ darunavir/ritonavir
- Viral load <50cp/mL at least 2 consecutive measurements (at least 3 month in between) with cART currently in use.
- able to sign informed consent
Exclusion Criteria
- Active opportunistic infections
- Hepatitis B coinfection AND treatment with drugs also used in HIV treatment (lamivudine, tenofovir)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in quality of life (QOL)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Investigation of the impact of switch to two high genetic barrier compounds on<br /><br>(I) residual replication (presence of plasma and intracellular HIV-RNA) (II)<br /><br>level of virus production from infected cells (reservoir; presence of HIV),<br /><br>(III) number of HIV virological failures and resistance analysis and (IV)<br /><br>Immunological markers (change in activation-, proliferation- and inflammation<br /><br>markers). </p><br>