HIV-1 Infection Clinical Trial
Official title:
Implementation of Out-of-HOspital Administration of the Long-Acting Combination Cabotegravir+Rilpivirine as an Optional Therapy in HIV-Infected Patients From Spain: Acceptability, Appropriateness, Feasibility and Satisfaction: The HOLA Study
HOLA is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase IV, double arm, open label, multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CAB+RPV, to evaluate the out-of-hospital administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.
Randomized patients will receive Long Acting (LA) cabotegravir (CAB) + rilpivirine (RPV) administration in the hospital (standard of care) or out-of-hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits, routinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03188523 -
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
|
Phase 1 | |
| Recruiting |
NCT02881320 -
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
|
Phase 2/Phase 3 | |
| Completed |
NCT02542852 -
A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia
|
Phase 2 | |
| Completed |
NCT02513771 -
Sitagliptin for Reducing Inflammation and Immune Activation
|
Phase 2 | |
| Terminated |
NCT02732457 -
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
|
||
| Completed |
NCT02057796 -
Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
|
Phase 4 | |
| Completed |
NCT01989910 -
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
|
Phase 4 | |
| Completed |
NCT01627678 -
Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART
|
Phase 1/Phase 2 | |
| Completed |
NCT01704781 -
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
|
Phase 1/Phase 2 | |
| Completed |
NCT01348308 -
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
|
Phase 3 | |
| Completed |
NCT01466595 -
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
|
Phase 2 | |
| Completed |
NCT01403051 -
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
|
Phase 2 | |
| Completed |
NCT01511809 -
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
|
Phase 3 | |
| Completed |
NCT01019551 -
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
|
Phase 2 | |
| Terminated |
NCT01130376 -
Novel Interventions in HIV-1 Infection
|
Phase 1 | |
| Completed |
NCT00323687 -
SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada
|
Phase 4 | |
| Completed |
NCT04003103 -
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
|
Phase 2 | |
| Completed |
NCT02527096 -
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
|
Phase 2 | |
| Active, not recruiting |
NCT04776252 -
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
|
Phase 3 | |
| Completed |
NCT02174159 -
Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003)
|
Phase 1 |