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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 January 2018
Main ID:  NCT02405013
Date of registration: 20/02/2015
Prospective Registration: Yes
Primary sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Public title: Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa TAC
Scientific title: TAC (Treatment Africa Hepatitis C) : Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa
Date of first enrolment: October 2015
Target sample size: 120
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02405013
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Cameroon Côte D'Ivoire Senegal
Contacts
Name:     Babacar Sylla
Address: 
Telephone:
Email:
Affiliation:  Institut de Médecine et d'Epidémiologie Appliquée
Name:     Raoul Moh, Dr
Address: 
Telephone:
Email:
Affiliation:  Programme PACCI
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age=18 years

- Confirmed G1, G2 or G4 HCV infection

- Plasma HCV-RNA =1000 IU/mL

- No history of HCV treatment of any kind

- Willingness to use a birth control method (hormonal or intrauterine device for women,
condoms for men), starting before HCV treatment initiation and continued until 4months
(women) and 7 months (men) after end of treatment.

- Weight =40 kg and =125 kg

For patients infected with HIV :

- Confirmed HIV-1 infection

- Stable HIV treatment for at least 8 weeks with two NRTIs (tenofovir or abacavir, and
lamivudine or emtricitabine) and a third agent (raltegravir, lopinavir/ritonavir,
atazanavir/ritonavir, darunavir/ritonavir, efavirenz, nevirapine)

- Current CD4+ lymphocytes count =100/mm3

- Current plasma HIV-1 RNA <200 copies/mL

Exclusion Criteria:

For each patient:

- Cirrhosis classified Child-Pugh B or C

- Co-infection by the Hepatitis B virus

- Pregnant or breastfeeding ongoing

- History of transplantation of organs or tissues

- Progressive Cancer, including hepatocellular carcinoma

- Epilepsy

- Sickle Cell Disease

- A history of myocardial infarction or other severe heart disease

- Excessive consumption of alcohol or drug users, in the absence of substitution by
methadone, a stable weaning for more than three months should be required

- Ongoing Participation in another clinical trial

- Contraindications to the Sofosbuvir as defined in the Summary of Product
Characteristics

- At least one of the following laboratory abnormalities:

Haemoglobin <10 g / 100 ml (woman) <11 g / 100 ml (man) Platelet count <50,000 / mm3
polymorphonuclear neutrophils rate <750 / mm3 Creatinine clearance <50ml / min

For patients infected with HIV:

- Severe opportunistic infections in the last 6 months

- Poor adherence to antiretroviral treatment history

- Use of antiretroviral drugs other than those permitted in the test



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
HIV Infection
Hepatitis C
Intervention(s)
Drug: Ribavirin
Drug: Sofosbuvir
Drug: Ledipasvir
Primary Outcome(s)
Sustained Viral Load Response (SVR) [Time Frame: Week 12]
Secondary Outcome(s)
Tolerance [Time Frame: 36 weeks]
Integration Access initiatives evaluated by the number of patients off protocol that will have access to new anti-HCV treatment due to "ACCESS" programs of pharmaceutical companies conducting such programs in Sub-Saharan Africa [Time Frame: 36 weeks]
Adherence measured by number of remaining tablets at each visit based on the number of tablets should have been taken as a percentage of the total dose [Time Frame: W4, W8, W12]
Biological events [Time Frame: W0, W24 and W36]
Performance of an unit of nanotechnology [Time Frame: 36 weeks]
Liver fibrosis [Time Frame: W0, W24 and W36]
Setting up the network: [Time Frame: 36 weeks]
Viral kinetics as measured by SVR 24 and HCV-RNA [Time Frame: W0, W2, W4, W12, W24, W36]
HIV treatment clinical parameters [Time Frame: 36 weeks]
Quality of life [Time Frame: 36 weeks]
Secondary ID(s)
ANRS 12311 TAC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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