Clinical trials: sponsored by ANRS, Emerging Infectious Diseases
COVID-19, Immunodeficiency
OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial
The overall purpose of the trial is to evaluate the efficacy and safety of possible combination antiviral therapy DAA (remdesivir + nirmatrelvir/r)∞ versus the reference monotherapy (nirmatrelvir/r alone) and to assess the…
- Trial name
- OPTICOV (NCT05587894)
- Testing
- Paxlovid 5 days, Paxlovid 10 days, Veklury
- Where
- 18 sites in France, Italy and 1 more
- Volunteers
- 256 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Hepatitis B Virus - Chronic Active
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women
Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) from the 28th week of amenorrhoea until 6 weeks after delivery.
- Trial name
- TOPCHIB (NCT05403047)
- Testing
- Fumarate, Tenofovir Disoproxil
- Where
- Cameroon
- Volunteers
- 150 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infection
Detection of Specific Metabolic Signatures by Nuclear Magnetic Resonance or Metabolomic NMR in Correlation With Markers of Inflammation or Immune Activation and the Risk of Developing Neurocognitive Disorders - Longitudinal Retrospective Study Nested in the ANRS12225 PEDIACAM III Cohort
The ANRS12225 PEDIACAM III cohort involves a cohort of young adolescents living with HIV placed early (median: 4 months) on antiretroviral therapy (ART) and living without HIV monitored in Cameroon.
- Trial name
- ANRS0213sMIND (NCT07770568)
- Volunteers
- 128 people
- Sponsor
- ANRS, Emerging Infectious Diseases
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
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
HIV Infection
Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence
This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level.
- Trial name
- TasP (NCT01509508)
- Testing
- Immediate ARV treatment initiation with TDF/FTC/EFV, South African recommendation guided ARV (TDF/FTC/EFV) initiation
- Where
- South Africa
- Volunteers
- 28,153 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Ebola Virus Disease
EBOla Post-Exposure Prophylaxis
EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms.
- Trial name
- EBO-PEP (NCT06841614)
- Testing
- Ervebo, Inmazeb
- Where
- 4 sites in Democratic Republic of the Congo, Guinea and 2 more
- Volunteers
- 160 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Tuberculosis, HIV-1-infection
Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression
DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial to compare the efficacy and the safety of an intensified tuberculosis (TB) regimen versus standard TB treatment in HIV-infected adults…
- Conditions
- Tuberculosis, HIV-1-infection, Immuno-Deficiency
- Trial name
- DATURA (NCT04738812)
- Testing
- Intensified TB treatment (initial phase), WHO standard TB treatment (initial phase)
- Where
- 6 sites in Cambodia, Cameroon and 4 more
- Volunteers
- 1,330 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HCV Infection
Study of DAA Treatment for Children and Adolescents With Active HCV Infection in Cambodia
The goal of this clinical trial is to evaluate the effectiveness of sofosbuvir/daclatasvir combination for children aged ≥ 6 years old and adolescents with active HCV infection in Cambodia
- Trial name
- HEPEDIAC (NCT05992077)
- Testing
- Sofosbuvir/Daclatasvir
- Where
- 4 sites in Cambodia
- Volunteers
- 21,000 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Japanese Encephalitis
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
The primary objective of this study is to quantify the clinical burden of Japanese Encephalitis (JE) and the asymptomatic circulation of JEV among Cambodian children, through two pediatric cohorts: non-febrile children at…
- Trial name
- DEMELE-JEV (NCT06674837)
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS…
- Trial name
- PediacamNEG (NCT06302933)
- Testing
- Blood sampling
- Where
- 3 sites in Cameroon
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV
Outcome at 5 Years of Early Treated HIV Infected Infants in the PEDIACAM Project
This study aims to assess the long-term outcomes of children infected with HIV, having participated in the ANRS 12140 PediacamI study, in terms of: clinical and immunovirological response to ARV therapy, long-term ARV tolerance…
- Trial name
- PEDIACAM (NCT02043418)
- Where
- 3 sites in Cameroon
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections, Hepatitis B
Health and Migration Trajectories of Housekeepers in Bamako
In Mali, migration from rural zones is a cultural phenomenon existing since 1970. During the dry season (9 months), an important number of young women leave their villages and migrate towards urban zones to seek for a job.
- Conditions
- HIV Infections, Hepatitis B, Hepatitis C, Tuberculosis
- Trial name
- 2DM2K (NCT05472051)
- Testing
- Community-based healthcare offer provided by an the ARCAD Santé PLUS NGO and integrated into the activities of the ADDAD NGO
- Where
- Mali
- Volunteers
- 644 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1
Prevention of Mother-to-child Transmission of HIV-1 Using a Responsive Intervention
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue…
- Trial name
- PROMISE-EPI (NCT03870438)
- Testing
- Lamivudine Oral Solution
- Where
- 6 sites in Burkina Faso, Zambia
- Volunteers
- 1,506 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1-infection
Primary Infection Cohort
Open, prospective, multicenter French cohort study enrolling subjects aged of 15 years or more, during or immediately after HIV-1 primary infection.
- Trial name
- PRIMO (NCT03148964)
- Testing
- blood sampling
- Where
- France
- Volunteers
- 2,800 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1
Preventing Childhood HIV: Rescue Intervention. ANRS 12388 PREVENIR-PEV
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue…
- Trial name
- PREVENIR-PEV (NCT03869944)
- Testing
- Lamivudine Oral Solution
- Where
- Burkina Faso
- Volunteers
- 97 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections
HUSH Restriction in HIV Infected Patients
HIV eradication faces a major obstacle that is viral persistence in latent reservoir cells despite antiretroviral therapy. Epigenetic repression plays a central role in viral transgene latency and several epigenetic regulators…
- Trial name
- NCT04172480
- Testing
- Blood sampling
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV/AIDS
Evaluation of Third-line cART Regimen in Cambodia (3DICAM)
The study aims to evaluate the virological effectiveness of a third-line regimen combining dolutegravir (DTG), ritonavir-boosted darunavir (DRV/r) and optimized NRTI in Cambodian HIV-infected adults, who failed a protease…
- Trial name
- NCT03602690
- Testing
- Dolutegravir + Darunavir/ritonavir + optimized NRTI
- Where
- Cambodia
- Volunteers
- 54 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Influenza -Like Illness, Covid19
Epidemiological Investigation of COVID-19 in Laos Using a One-Health Approach in Human and Animals
The Respiratory infection COVID-19, due to a new coronavirus, SARS-CoV2, appeared in December 2019 in several people who attended the wildlife market in Wuhan, Hubei Province, China.
- Trial name
- LACOVISS (NCT04716543)
- Testing
- ILI and COVID-19 detection
- Volunteers
- 5,400 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1-infection
ANRS 12406 EvvA Study
ANRS 12406 EvvA is an observational, longitudinal and monocentric study evaluating the virological success rate in HIV-infected adolescents on antiretroviral therapy in Cameroon.
- Trial name
- EvvA (NCT04593979)
- Where
- Cameroon
- Volunteers
- 289 people
- Sponsor
- ANRS, Emerging Infectious Diseases