HIV Infection Clinical Trial
— MOVIDA-Hep2Official title:
Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam
NCT number | NCT05506475 |
Other study ID # | 2021-084 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | April 2025 |
With the advent of direct acting antiviral (DAA) treatment in 2013, HCV elimination has become feasible. Still, achieving HCV elimination in resource-limited countries appears to be arduous as several challenges need to be addressed. In remote settings, absence of HCV VL testing to identify those who require DAA and to monitor DAA success is a first issue. As of today, HCV VL testing is still restricted to central facilities in major cities. Blood sampling using DBS is an appealing option to allow HCV VL monitoring in remote settings as this option is inexpensive, does not require a cold chain for storage and transportation of the samples and can be implemented rapidly. A second issue is DAA access that remains scarce due to logistical and financial limitations. However, more affordable generic DAA, some of them being WHO pre-qualified, are now available. Vietnam is amongst the 20 countries with the highest HCV burden with an estimate of 1.5 million chronic HCV-infected people (HCV prevalence: 1.1%). As observed in many other settings, HCV prevalence is higher among vulnerable populations such as HIV-infected individuals and people who inject drugs (PWID). Vietnam has the will to increase access to DAA in the whole country. However, in remote settings, only some clinical sites will be allowed to dispense DAA. Discussions with the MoH of Vietnam brought to our knowledge that not all clinical sites caring for HIV patients and providing ART will dispense DAA. Thus, some HIV-HCV co-infected patients will be followed in clinical sites where they will receive both antiretroviral therapy and DAA, while some other patients will continue to be followed for HIV in their usual clinical site but will be asked to visit another clinical site for HCV care and to receive DAA. We anticipate that the proportion of patients who will comply with the 12-week DAA will be lower in patients followed for HIV and HCV in two clinical sites than in those followed in a single clinical site.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age at enrolment =18 years. - Documented HIV-1 infection. - HCV infection documented by the presence of Anti-HCV antibodies or a positive RDT; if the result was negative but dates from more than 6 months the patient will be tested again. - Consent to participate in the study Exclusion Criteria: - HCV negative patient. - Patient not routinely followed for HIV care in the clinical sites participating in the study. - Previous treatment by DAA. - Patient for whom the health status, according to the medical staff, may interfere with the study or is not compatible with the sampling planned in the study |
Country | Name | City | State |
---|---|---|---|
Vietnam | Center for Diseases Control and Prevention of Nghe An province | Vinh | Nghe An |
Vietnam | Center for Disease Control and Prevention of Yen Bai Province | Yên Bái | Yen Bai |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur | ANRS, Emerging Infectious Diseases, National Institute of Hygiene and Epidemiology, Vietnam |
Vietnam,
Tran TH, Nguyen BT, Nguyen TA, Pham TTP, Nguyen TTT, Mai HTB, Pham HB, Nguyen TM, Phan HTT, Do NT, Ait-Ahmed M, Taieb F, Madec Y. Dried blood spots perform well to identify patients with active HCV infection in Vietnam. J Viral Hepat. 2020 May;27(5):514-519. doi: 10.1111/jvh.13263. Epub 2020 Feb 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare compliance to the 12-week DAA treatment between patients followed in the same clinical site for HIV and HCV infections, and patients followed in two clinical sites for these two infections | Proportion of patients who have taken =90% of daily doses during the 12-week DAA (measured by pill count). | 12 weeks | |
Secondary | To describe the compliance to the 12-week DAA treatment, and identify factors associated with good compliance | Number of days the DAA treatment was taken (measured by pill count), | 12 weeks | |
Secondary | To evaluate and compare the efficacy of the DAA treatment (defined by SVR12), and identify factors associated with SVR12 | Proportions of patients achieving SVR12, defined by an undetectable HCV VL 12 weeks after the planned end date of DAA treatment, | 24 weeks | |
Secondary | To describe the HCV genotypes circulating | Characterization of HCV genotypes and subtypes by means of Sanger sequencing | 24 weeks | |
Secondary | To describe HCV drug resistances in those not achieving SVR12, | Full-length HCV genome sequence analysis, by means of shotgun metagenomics using deep sequencing, for patients who did not achieve SVR12 | 24 weeks | |
Secondary | To estimate the rate of HCV re-infection within 24 months after SVR12 | HCV VL measured 12 and 24 months after SVR12 | 30 months | |
Secondary | To evaluate and compare quality of life in HIV-HCV co-infected patients before and after DAA treatment. | Quality of life evaluated through the 5-level EQ-5D version (EQ-5D-5L) quality of life scale (scale is numbered from 0 to 100, 100 means the best health the participant can imagine / 0 means the worst health the participant can imagine), measured prior to and 1 year after the end of DAA treatment. | 18 months |
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