Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502882-53-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffering certain psychological disorders.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAB LA + RPV LA | Experimental | the proportion of participants ≥60 years on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12 in the intention-to- treat exposed (ITT-E) population |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabotegravir LA + Rilpivirine LA | Drug | Cabotegravir (CAB) LA 600mg and Rilpivirine (RPV) LA 900mg will be administered intramuscularly every 2 months after an induction phase with a single administration in months 1 and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Numer of patients on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL | Proportion of participants ≥60 years on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12 in the intention-to-treat exposed (ITT-E) population, per the FDA Snapshot algorithm. | Up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of HIV-1 RNA Copies | To evaluate other estimations of virological control and number of episodes of plasma HIV-1 RNA ≥50 copies/mL that do not meet the criteria for confirmed virological failure | 6, 12 and 24 Months |
| Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| CD4/CD8 ratio | To assess the change in CD4/CD8 ratio | 6, 12 and 24 Months |
| HIV Status | Questionnaire status version (HIVTSQs), | 6, 12 and 24 Months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrique Bernal Morell Jefe de Servicio de Medicina Interna. Hospital General Univer, MD | Contact | 968 35 90 00 | ebm.hgurs@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Not yet recruiting | Elche | Alicante | 03203 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase IV study, prospective, open-label, single arm, multicentre, with a follow-up of 24 months
Not provided
Not provided
Not provided
Not provided
To determine the proportion of participants experiencing confirmed virologic failure |
| 12 and 24 Months |
| Number of Participants with experienced CVF (confirmed virologic failure) | To asses treatment emergent genotypic and phenotypic resistance in participants experiencing CVF. Levels of hiv-1 RNA copies | 6, 12 and 24 Months |
| To evaluate the immune effects of switching to CAB LA + RPV LA | Plasma levels of (CD4 and CD4/CD8), | 6, 12 and 24 Months |
| Number of SAES/SUSAR in patients treated with CAB LA + RPV LA | evaluation of parameters ensuring efficacy and security of patients, Number of SAES/SUSAR | 6, 12 and 24 Months |
| HIV Treatment Satisfaction | Perception of injection questionnaire (PIN) | 6, 12 and 24 Months |
| Hospital Marina Baixa | Not yet recruiting | Villajoyosa | Alicante | 03570 | Spain |
|
| Hospital General Universitario Santa Lucía | Not yet recruiting | Cartagena | Murcia | 30202 | Spain |
|
| Hospital Universitario Rafael Mendéz de Lorca | Not yet recruiting | Lorca | Murcia | 30813 | Spain |
|
| Hospital General Universitario Reina Sofia | Recruiting | Murcia | Murcia | 30003 | Spain |
|
| Hospital General Universitario Morales Meseguer | Not yet recruiting | Murcia | Murcia | 30008 | Spain |
|
| Hospital Clinico Universitario Virgen de la Arrixaca Murcia | Not yet recruiting | Murcia | Murcia | 30100 | Spain |
|
| Hospital General Universitario Los Arcos del Mar Menor | Not yet recruiting | Pozo-Aledo | Murcia | 30739 | Spain |
|