Clinical Research Directory

Evaluating the Safety and Immunogenicity of MTBVAC

The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa

A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/

Following the initiation of Doravirine (DOR) regimen among people living with HIV (PLWH), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period. Retrospective data from 500 patients is planned to be collected from 6 - 10 European sites. Cohort 1 : 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, Cohort 2: 50 patients with NNRTI mutations (other than DOR), Cohort 3: 50 patients with NNRTI mutations (including DOR). The study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®) in patients infected with HIV-1, depending on the injection site and whether or not they are wearing a virtual reality headset. The reference group being the dorsogluteal injection without headset. Participants who meet the study criteria will be randomized into 1 of 24 sequences. A sequence is composed by 4 injections procedures: dorsogluteal intramuscular injection (A), ventrogluteal intramuscular injection (B), dorsogluteal intramuscular injection with virtual reality headset (C), ventrogluteal intramuscular injection with virtual reality headset (D). Each patient will be their own witness and will experience the 4 intramuscular injection procedures of injectable antiretroviral. The study population are patients carrying HIV-1 and being monitored for this pathology, eligible (naïve patients) or already under Cabotegravir® (CAB) and Rilpivirine® (RPV) injectable treatment.

Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy

The purpose of this study is to evaluate whether a single dose of Nivolumab in people living with HIV can reduce the latent reservoir. The latent HIV reservoir is a group of immune system cells in the body that are infected with HIV but are not actively producing new virus. This is the reason why people living with HIV are unable to stop their antiretroviral treatment.

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).

Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe

The goal of this observational study is to improve cervical pre-cancer treatment outcomes among women living with HIV (WLWH), particularly in low and middle income countries (LMICs), by generating the evidence needed for post-treatment monitoring guidelines. The main questions it aims to answer are: * What is the risk of disease recurrence/persistence after cervical pre-cancer treatment among women living with HIV in Zimbabwe? * What is the predictive value of different human papillomavirus (HPV) and DNA methylation testing strategies for monitoring cervical disease recurrence/persistence after pre-cancer treatment? Participants will have cervical biopsies taken for histological assessment and cervical samples for HPV genotyping and DNA methylation testing. Researchers will follow all participating women every six months for 24 months to evaluate post-treatment monitoring and cervical disease outcomes.

Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. The proposed study will test theory-based interventions designed to manage HIV stigma in order to improve care retention and medication adherence in communities with high-levels of HIV-related stigma.

Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals

A modern and urgent challenge in fighting HIV infection is to achieve sustained HIV remission without the use of antiretrovirals. The investigators' preliminary data indicate that the use of combined strategies to mitigate the HIV proviral reservoir size among individuals with suppressive antiretroviral treatment achieved unprecedented results in the reduction of HIV DNA present in these cells and in the reduction of CD4 + and CD8 + T cell activation. Combined interventions include intensified antiretroviral treatment to mitigate residual HIV replication, use of a histone deacetylase inhibitor to interrupt viral latency, use of an anti-proliferative medication to reduce long-lived T cells that harbor HIV and a personalized dendritic cell therapy vaccine to eliminate cells with latent HIV infection or cells present in viral sanctuaries. Due to the good results obtained in the exploratory stage of the project, the investigators propose to expand it by recruiting a larger number of patient to confirm the previously obtained results and to generate new insights related to the mechanisms involved in viral latency, latency disruption and the effects of analytical treatment interruption of antiretrovirals among patients undergoing all above mentioned interventions.

Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France

For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable viral suppression. People with multidrug-resistant HIV-1 are at increased risk for hospitalization, progression to acquired immunodeficiency syndrome, and death. Lenacapavir (LEN) is a first-in-class capsid inhibitor and has been evaluated through the CAPELLA phase 3 trial in PWH with replicative multidrug-resistant HIV-1. In this trial, LEN combined with an optimized background regimen (OBR) led to high levels of viral suppression, as more than 80% of participants achieved undetectable plasma HIV-RNA, associated with increasing in CD4 T cell counts. LEN has become publicly available in France from June 20, 2023, and prescriptions are discussed and validated by multidisciplinary committees in the hospitals, including HIV physicians, virologists and pharmacologists. From the time LEN was made publicly available in France, no real-world data have been generated to describe the real-world use of LEN, in association with an OBR, in various patient's profiles who may differ from the subjects included the CAPELLA trial. Thus, investigators plan to conduct a national, multicenter, retrospective observational study to describe baseline socio-demographic, clinical and biological profiles of PWH receiving LEN + OBR in French real-world settings, to determine the continuation of LEN injections at weeks 26 and 52, and to determine the reasons for stopping LEN in case of no continuation of LEN injections. In its current indication, LEN is reserved for a minority of PWH. However, France is the second-largest prescribing country for this drug, and one year after it was first marketed, it seems essential to review its use. Whether LEN injections are continued 6 and 12 months after starting treatment is a crucial question for understanding its use in treatment centers. Lenacapavir has become publicly available in France in June 20, 2023. LEN prescriptions in France are discussed and validated by multidisciplinary committees, including HIV physicians, virologists and pharmacologists in the hospitals.

The Expand Study-Pharmacist Administered Long Acting Cabotegravir + Rilpivirine to Expand Access for People With HIV

The purpose of The EXPAND study is to develop and pilot a pharmacist led model of medication delivery. Following a co-design phase, patients may receive injections at satellite pharmacies by a licensed pharmacist. The acceptability, appropriateness, and feasibility of this approach and standard in clinic administration by a nurse will be assessed.