HIV-1 Infected Adults With Controlled ViremiaPhase 4LOVER60NCT06646562

Long Acting Cabotegravir Plus Rilpivirine in People Living With HIV-1 Aged ≥ 60 Years for 24 Months.

A Phase 4 study testing Cabotegravir LA + Rilpivirine LA in people with HIV-1 Infected Adults With Controlled Viremia, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 8 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: HIV-1 Infected Adults With Controlled Viremia
What is being tested?: Cabotegravir LA + Rilpivirine LA
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 8 sitesSpain
Study dates: 3 Mar 2025to 30 Dec 2027
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Spain8 sites

Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital Universitario Rafael Mendéz de Lorca
Lorca, Murcia, 30813
Hospital General Universitario Reina Sofia
Murcia, Murcia, 30003
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008
Hospital Clinico Universitario Virgen de la Arrixaca Murcia
Murcia, Murcia, 30100
Hospital General Universitario Los Arcos del Mar Menor
Pozo-Aledo, Murcia, 30739
Hospital Marina Baixa
Villajoyosa, Alicante, 03570

Other trials in Spain

About this study

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.

Conditions: HIV-1 Infected Adults With Controlled Viremia
Being tested: Cabotegravir LA + Rilpivirine LA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cabotegravir LA + Rilpivirine LADrug
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.

Study groups in NCT06646562
Study group	Role	What they receive
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 Receives: Drug: Cabotegravir LA + Rilpivirine LA

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 12 Months

Secondary outcomes (5)

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
Measured: 6, 12 and 24 Months
Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL)
To determine the proportion of participants experiencing confirmed virologic failure
Measured: 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
Measured: 6, 12 and 24 Months
To evaluate the immune effects of switching to CAB LA + RPV LA
Plasma levels of (CD4 and CD4/CD8),
Measured: 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
Measured: 6, 12 and 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202530 Dec 2027

First posted17 Oct 2024
Study start3 Mar 2025
Primary completion30 Jun 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV-1 Infected Adults With Controlled ViremiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Phase IV study, prospective, open-label, single arm, multicentre, with a follow-up of 24 months
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06646562
Sponsor's protocol ID: IMIB-LOVER60-2022-03
Other IDs: 2022-502882-53-00
Acronym: LOVER60
Status last verified: Oct 2026
First submitted: 11 Oct 2024
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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