Clinical trials: sponsored by ANRS, Emerging Infectious Diseases
Lassa Fever
ARN-75039 Lassa Fever Treatment in West Africa
This multicenter, randomized, open-label Phase 2 clinical trial evaluates the safety, tolerability, and virologic efficacy of ARN-75039, a novel oral antiviral, for treating Lassa fever in hospitalized adults in West Africa.
- Trial name
- NCT07419373
- Testing
- ARN-75039 high, Intravenous ribavirin, ARN-75039 low
- Where
- 4 sites in United States, Nigeria
- Volunteers
- 135 people
- Sponsor
- Arisan Therapeutics, Inc.
Post-acute COVID-19 Syndrome
Education of Medical Staff to Post Acute Covid susTained sYmptoms
Evaluation of the effectiveness of a training and support intervention for general practitioners treating patients with persistent symptoms after a COVID-19 episode on the patients'quality of life at 3 months.
- Trial name
- EMPATY (NCT06082258)
- Testing
- Training in the management of functional disorders, Reimbursement of 3 long consultations
- Where
- 7 sites in France
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Tuberculous Meningitis
Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis
INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults…
- Trial name
- INTENSE-TBM (NCT04145258)
- Testing
- Aspirin, WHO TBM treatment, Intensified TBM treatment
- Where
- 13 sites in Côte d’Ivoire, Madagascar and 2 more
- Volunteers
- 768 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1 Infection, HIV Reservoir
Intestinal Tissue-Resident Memory T Cells and HIV-1 Persistence During Antiretroviral Therapy
The study aims to better characterize intestinal tissue-resident memory T cells (TRM) in people living with HIV-1 receiving suppressive antiretroviral therapy (ART).
- Conditions
- HIV-1 Infection, HIV Reservoir, Antiretroviral Therapy
- Trial name
- ANRSGALT-2 (NCT07656077)
- Testing
- Colonic Mucosal Biopsies
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Hepatitis C, Chronic, Fibrosis
Efficacy of Prazosin Versus Placebo Associated With Peg-interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with…
- Trial name
- PRAZOR (NCT00148837)
- Testing
- Peg-interferon alpha 2b + Ribavirin(drug), Prazosin (drug)
- Where
- France
- Volunteers
- 112 people
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
HIV Infections, Antiretroviral Naive
Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence.
- Trial name
- NCT00196599
- Testing
- emtricitabine, FTC (drug), didanosine, ddI (drug), efavirenz (drug)
- Where
- France
- Volunteers
- 39 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections, Hepatitis C
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV…
- Trial name
- NCT00158535
- Testing
- liver transplantation
- Where
- France
- Volunteers
- 15 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-infected Patients in Virological Failure.
HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure.
- Trial name
- NCT00196625
- Testing
- Amprenavir (drug), ABT-378/r (drug), Ritonavir (drug)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
Antibody Responses to Pneumococcal Vaccines Among HIV-infected Adults.
Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3.
- Trial name
- NCT00148824
- Testing
- 7-valent pneumococcal conjugate vaccine (vaccine), 23-valent pneumococcal conjugate vaccine (vaccine)
- Where
- France
- Volunteers
- 212 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults.
- Trial name
- NCT00196612
- Testing
- emtricitabine, FTC (drug), didanosine, ddI (drug), efavirenz (drug)
- Where
- France
- Volunteers
- 350 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Tuberculosis
Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)
The French Tuberculosis Cohort is a prospective, national, multicenter, low-intervention study including subjects aged 18 years and older with tuberculosis disease for which inpatient treatment is initiated.
- Trial name
- FrenchTB (NCT06893757)
- Where
- 2 sites in France
- Volunteers
- 2,000 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Hepatitis C
Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir
The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the…
- Trial name
- NCT02647632
- Testing
- Grazoprevir/Elbasvir, Sofosbuvir, Ribavirin
- Where
- 13 sites in France
- Volunteers
- 26 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1-infection, Subtype b
Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load
The ANRS 171 SYNACTHIV trial is a monocenter pilot open label phase I trial. This trial will evaluate new procedures in LRA administration in 3 successive cohorts.
- Trial name
- SYNACTHIV (NCT05230368)
- Testing
- Decitabine cycle 1, Romidepsin cycle 1, Decitabine cycle 2
- Where
- 4 sites in Belgium, France
- Volunteers
- 9 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Healthy Adults
A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults
EHVA P01 is an international, phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.
- Trial name
- EHVA P01 (NCT04844775)
- Testing
- Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L, DREP-HIV-PT1 1mg and CN54gp140/MPLA-L (see above), DNA-HIV-PT123 4mg and CN54gp140/MPLA-L
- Where
- 4 sites in France, Switzerland and 1 more
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1-infection
Reducing Antiretroviral Treatments
The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a 16 week…
- Trial name
- ALTAR (NCT04051970)
- Testing
- Antiretroviral
- Where
- France
- Volunteers
- 360 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Chronic Hepatitis C
Study Comparing the Tolerability and Viral Reduction of the Combination of IFN a-2b XL + Ribavirin Versus Peg IFN a-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4
Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with…
- Trial name
- COAT IFN (NCT01010646)
- Testing
- IFN alfa-2b XL 27 MUI + Ribavirin, IFN alfa-2b XL 36 MUI + Ribavirin, IFN peg alfa-2b 1.5 µg/kg + Ribavirin
- Where
- France
- Volunteers
- 84 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Healthy Adults
An Experimental Medicine Multicenter Trial to Evaluate the Safety and Immunogenicity of Experimental Versus Authorized SARS-CoV-2 Vaccine Candidates as a Booster Dose in Healthy Participants Previously Vaccinated With Authorized mRNA SARS-CoV-2 Vaccines.
The SOLVE-01 trial is a study evaluating four SARS-CoV-2 vaccines as booster injections: two experimental vaccines (CD40.RBDv and CD40.Pan.CoV, both combined with the Hiltonol® adjuvant) and two authorised vaccines (Comirnaty®…
- Trial name
- SOLVE-01 (NCT07605520)
- Testing
- CD40.RBDv vaccine adjuvanted with Hiltonol®, CD40.Pan.CoV vaccine adjuvanted with Hiltonol®, Comirnaty® vaccine
- Where
- 3 sites in France, Switzerland
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Monkeypox, Mpox
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease
The overall purpose of this study is to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and older).
- Trial name
- UNITY (NCT05597735)
- Testing
- Tecovirimat
- Where
- 12 sites in Argentina, Brazil and 1 more
- Volunteers
- 480 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Mpox (Monkeypox)
Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort
Primary objective The overall objective is to assess the long-term amplitude and durability of the immune responses after mpox virus (MPXV) infection.
- Trial name
- POXAIM (NCT07592429)
- Testing
- blood sampling
- Volunteers
- 60 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Healthy Volunteers
Dose Escalation Trial of CD40.Pan.CoV Vaccine, Adjuvanted or Not, as a Booster in Adult Healthy Volunteers
The clinical trial is a phase1/2a, open-label, dose-escalating, multicentre trial evaluating the safety and immunogenicity of the CD40.Pan.CoV vaccine, adjuvanted or not, as a booster injection in adult participants in France.
- Trial name
- PANCOV (NCT07113106)
- Testing
- CD40.Pan.CoV Low dose(0.25mg), CD40.Pan.CoV Low dose (0,25mg) adjuvanted with Hiltonol®, CD40.Pan.CoV High dose (1mg)
- Where
- 7 sites in France
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases