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NCT ID: NCT03387397 Recruiting - Clinical trials for HIV Infection Primary

Assessing Differential Adherence to Medications and Quality of Life Among People Living With HIV and Comorbidities

TEAMH
Start date: December 12, 2017
Phase: N/A
Study type: Interventional

The investigators propose to utilize quantitative and qualitative methodology to better understand the impact of multiple drug use (polypharmacy) on medication adherence as well as the driving forces behind differential adherence in people living with HIV (PLWH) with comorbidities. Since the clinical relevance of differential adherence to antiretroviral therapy (ART) medication has already been demonstrated and associated with virologic failure and a more rapid progression to AIDS and death, it is imperative to understand the driving forces behind differential adherence (selective drug taking) and its impact on treatment outcomes in PLWH with comorbidities. Moreover, the use of technology to improve medication adherence is receiving much attention, and there are several smartphone applications that send medication reminders and generate personalized text messages to further motivate users. This type of technology could be particularly beneficial to patients who are managing multiple medications for multiple conditions. To this end, the investigators propose to use the medication adherence smartphone-based application, 'Technology for Engagement And Management of Health (TEAMH) to track both medication adherence and medication side effects in real-time among PLWH with comorbidities. TEAMH is an interactive health care information technology system that is not only patient-centered in that it encourages patient engagement in health care self-management, but also offers significant cost savings by directly connecting patients with their health care providers allowing providers to quickly address any health issue that may arise, thus potentially avoiding costly hospitalizations later on.

NCT ID: NCT02976259 Not yet recruiting - Clinical trials for HIV Infection Primary

Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection

DOLUPRIM
Start date: December 2016
Phase: Phase 3
Study type: Interventional

Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56 Coordinating investigator: Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses 1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail : caroline.lascoux-combe@aphp.fr Participating country : FRANCE Primary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF (TDF) + emtricitabine (FTC) at the time of PHI. Secondary objectives : - Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48 - To assess the frequency of intermittent shedding in seminal plasma once virological suppression has been achieved and until W48 - Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48 - Comparison of dolutegravir concentration in blood plasma and seminal plasma - Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma - Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved (i.e. at D0 and W12) Inclusion criteria : - Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for HIV antibodies followed within 3 months by a positive HIV serology - Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of PHI - Genotypic sensitivity to TDF, FTC and DTG - Patient with medical care insurance Exclusion criteria : - Chronic infection - Infection or co-infection with HIV-2 Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients (exploratory study)