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

NCT06646562 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • HIV-1 Infected Adults with Controlled Viremia

Interventions

DRUG

Cabotegravir 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 & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-01-30
Completion
2027-01-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646562 on ClinicalTrials.gov