Clinical trials: sponsored by 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, 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
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
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
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
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
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
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
Hiv Infection
Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men
Multicentric epidemiological non-comparative study in France characterising evolution of anal Human papillomavirus (HPV) infection and related lesions and evaluating markers associated with the observed evolution.
- Trial name
- APACHES (NCT02287961)
- Testing
- Standard proctologic examination, High resolution anoscopy, Biopsy(ies) during High Resolution Anoscopy
- Where
- France
- Volunteers
- 516 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Hiv Infection, Lung Cancer
Early Lung Cancer Diagnosis in HIV Infected Population With an Important Smoking History With Low Dose CT: a Pilot Study
Early Lung Cancer diagnosis in a HIV-infected population with an important smoking history with low-dose CT: a pilot study: the HIV-CHEST study Objectives The main objective of this study is to evaluate the prevalence of lung…
- Trial name
- EP48 HIV CHEST (NCT01207986)
- Testing
- Low dose computed tomography (CT)
- Where
- France
- Volunteers
- 450 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infection
Residual Replication of HIV-1 in the Gut Associated Lymphoid Tissue (GALT) of Patients on Highly Active Antiretroviral Therapy (HAART): the ANRS EP 44 Study
HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication.
- Trial name
- EP 44 (NCT01038401)
- Testing
- GI endoscopy and GALT biopsies, A sample of venous blood will also be collected
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1 Infection
Gut-Associated Lymphocyte Trafficking
The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the gut lumen into the bloodstream that fuels…
- Trial name
- GALT (NCT02906137)
- Testing
- Peripheral blood and intestinal biopsies will be collected
- Where
- 2 sites in France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Hiv Infection
X-linked Biological Response to HIV Sensing: the ANRS EP 53 Study
Short title : X-linked biological response to HIV sensing: the ANRS EP 53 study. Main outcome : To demonstrate that HIV-infected women carry the TLR7 c.32A>T SNP at a higher frequency than uninfected women, arguing in favor of a…
- Trial name
- X LIBRIS (NCT01952587)
- Testing
- A peripheral blood sample
- Where
- France
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV/AIDS
Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)
This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West…
- Trial name
- CohMSM-PrEP (NCT03459157)
- Testing
- HIV prevention package including PrEP
- Where
- 4 sites in Burkina Faso, Côte d’Ivoire and 2 more
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases