Long Acting Cabotegravir Plus Rilpivirine in People Living With HIV-1 Aged ≥ 60 Years for 24 Months. (LOVER60)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Alicante
-
Elche, Alicante, Spanien, 03203
- Hospital General Universitario de Elche
-
Villajoyosa, Alicante, Spanien, 03570
- Hospital Marina Baixa
-
-
Murcia
-
Cartagena, Murcia, Spanien, 30202
- Hospital General Universitario Santa Lucía
-
Lorca, Murcia, Spanien, 30813
- Hospital Universitario Rafael Mendéz de Lorca
-
Murcia, Murcia, Spanien, 30008
- Hospital General Universitario Morales Meseguer
-
Murcia, Murcia, Spanien, 30003
- Hospital General Universitario Reina Sofia
-
Murcia, Murcia, Spanien, 30100
- Hospital Clinico Universitario Virgen de la Arrixaca Murcia
-
Pozo-Aledo, Murcia, Spanien, 30739
- Hospital General Universitario Los Arcos del Mar Menor
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: CAB LA + RPV LA
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 |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Numer of patients on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL
Tidsram: 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. |
Up to 12 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Levels of HIV-1 RNA Copies
Tidsram: 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 |
6, 12 and 24 Months
|
|
Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL)
Tidsram: 12 and 24 Months
|
To determine the proportion of participants experiencing confirmed virologic failure |
12 and 24 Months
|
|
Number of Participants with experienced CVF (confirmed virologic failure)
Tidsram: 6, 12 and 24 Months
|
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
Tidsram: 6, 12 and 24 Months
|
Plasma levels of (CD4 and CD4/CD8), |
6, 12 and 24 Months
|
|
Number of SAES/SUSAR in patients treated with CAB LA + RPV LA
Tidsram: 6, 12 and 24 Months
|
evaluation of parameters ensuring efficacy and security of patients, Number of SAES/SUSAR |
6, 12 and 24 Months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CD4/CD8 ratio
Tidsram: 6, 12 and 24 Months
|
To assess the change in CD4/CD8 ratio |
6, 12 and 24 Months
|
|
HIV Status
Tidsram: 6, 12 and 24 Months
|
Questionnaire status version (HIVTSQs), |
6, 12 and 24 Months
|
|
HIV Treatment Satisfaction
Tidsram: 6, 12 and 24 Months
|
Perception of injection questionnaire (PIN) |
6, 12 and 24 Months
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IMIB-LOVER60-2022-03
- 2022-502882-53-00 (Ctis)
Plan för individuella deltagardata (IPD)
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