HIV-1 Infected Adults with Controlled Viremia
Conditions
Brief summary
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.
Interventions
DRUGCabotegravir LA + Rilpivirine LA
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.
Sponsors
ViiV Healthcare
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase IV study, prospective, open-label, single arm, multicentre, with a follow-up of 24 months
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be able to understand and comply with protocol requirements, instructions, and restrictions. * Understand the long-term commitment to the study and be likely to complete the study as planned. * Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.). * Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. * Plasma HIV-1 RNA \<50 copies/mL at screening. * A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test at screen and a negative urine hCG test at randomization) and not lactating
Exclusion criteria
* Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blips are allowed (increased viral load ≥50 copies/mL but \<200 copies/mL preceded and followed by a viral load less than 50 copies/mL) * Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns. * Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as a confirmed plasma HIV-1 RNA measurement ≥200 copies/mL after initial suppression to \<50 copies/mL while on first line HIV therapy regimen) * Subjects who are currently participating in or anticipate being selected for any other interventional study. Observational studies and intervention studies that do not include treatments are allowed unless they interfere with scheduled visits. * Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numer of patients on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL | Up to 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL) | 12 and 24 Months | To determine the proportion of participants experiencing confirmed virologic failure |
| Number of Participants with experienced CVF (confirmed virologic failure) | 6, 12 and 24 Months | To asses treatment emergent genotypic and phenotypic resistance in participants experiencing CVF. Levels of hiv-1 RNA copies |
| To evaluate the immune effects of switching to CAB LA + RPV LA | 6, 12 and 24 Months | Plasma levels of (CD4 and CD4/CD8), |
| Number of SAES/SUSAR in patients treated with CAB LA + RPV LA | 6, 12 and 24 Months | evaluation of parameters ensuring efficacy and security of patients, Number of SAES/SUSAR |
| Levels of HIV-1 RNA Copies | 6, 12 and 24 Months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| HIV Treatment Satisfaction | 6, 12 and 24 Months | Perception of injection questionnaire (PIN) |
| CD4/CD8 ratio | 6, 12 and 24 Months | To assess the change in CD4/CD8 ratio |
| HIV Status | 6, 12 and 24 Months | Questionnaire status version (HIVTSQs), |
Countries
Spain
Contacts
Primary ContactEnrique Bernal Morell Jefe de Servicio de Medicina Interna. Hospital General Univer, MD
Outcome results
None listed