Hepatitis C Virus Infection, Response to Therapy ofPhase 3HIV200NCT03369327
Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
A Phase 3 study testing sofosbuvir and daclatasvir in people with Hepatitis C Virus Infection, Response to Therapy of and Human Immunodeficiency Virus, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial summary
In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus
- What is being tested?
- sofosbuvir and daclatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesIran
- Study dates
- 1 Jan 2017to 1 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
- Positive human immunodeficiency virus test
Who cannot join
- Heart rate < 50/min,
- Taking amiodarone
- Renal failure
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
Read the detailed description
To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These subjects offer a particular challenge as they are receiving ART which frequently interferes with hepatitis treatment. The number of pills they are already taking also limits the compliance of these patients.
In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed.
The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
The study is one of the pilots being run for hepatitis C elimination in Iran.
- Being tested
- sofosbuvir and daclatasvir
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir and daclatasvirDrug
Also called Sovodak 30/400, Sovodak 60/400, Sovodak 90/400
Depending on the ART received by each patient one of the fixed-dose combination pills below will be used:
- Daclatasvir 30 mg and sofosbuvir 400 mg
- Daclatasvir 60 mg and sofosbuvir 400 mg
- Daclatasvir 90 mg and sofosbuvir 400 mg
| Study group | Role | What they receive |
|---|---|---|
| sofosbuvir/daclatasvir | Experimental | Once daily fixed-dose combination pill of sofosbuvir and daclatasvir for 12 weeks if the patient is non cirrhotic and for 24 weeks if cirrhotic Receives: Drug: sofosbuvir and daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sustained viral response rate
Qualitative hepatitis C virus RNA polymerase chain reaction
Measured: 12 weeks after end of treatment
Secondary outcomes (1)
Adverse drug events
Questionnaire
Measured: weeks 2, 4, 8, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Jan 2017
- Primary completion1 Sep 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus Infection, Response to Therapy ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- RojanPharma Pharmaceutical Company
- Responsible party
- Sponsor
- Investigators
- Reza Malekzadeh, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369327
- Sponsor's protocol ID
- 95-04-159-34058
- Acronym
- HIV200
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dehghan Manshadi SA, Merat S, Mohraz M, Rasoolinejad M, Sali S, Mardani M, Tabarsi P, Somi MH, Sedghi R, Tayeri K, Nikbin M, Karimi J, Sharifi AH, Kalantari S, Norouzi A, Merat D, Malekzadeh Z, Mirminachi B, Poustchi H, Malekzadeh R. Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. Int J Clin Pract. 2021 Aug;75(8):e14304. doi: 10.1111/ijcp.14304. Epub 2021 May 17.
PubMed 33930223
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT03369327
- Acronym / sponsor ID
- HIV200 / 95-04-159-34058
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- RojanPharma Pharmaceutical Company
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
Detailed description
To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These subjects offer a particular challenge as they are receiving ART which frequently interferes with hepatitis treatment. The number of pills they are already taking also limits the compliance of these patients.
In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed.
The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
The study is one of the pilots being run for hepatitis C elimination in Iran.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sofosbuvir/daclatasvir | Experimental | Drug: sofosbuvir and daclatasvirOnce daily fixed-dose combination pill of sofosbuvir and daclatasvir for 12 weeks if the patient is non cirrhotic and for 24 weeks if cirrhotic |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
- Positive human immunodeficiency virus test
Key exclusion criteria (3 listed)
- Heart rate < 50/min,
- Taking amiodarone
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sofosbuvir and daclatasvirAlso: Sovodak 30/400, Sovodak 60/400, Sovodak 90/400Depending on the ART received by each patient one of the fixed-dose combination pills below will be used: 1. Daclatasvir 30 mg and sofosbuvir 400 mg 2. Daclatasvir 60 mg and sofosbuvir 400 mg 3. Daclatasvir 90 mg and sofosbuvir 400 mg | Drug | sofosbuvir/daclatasvir |
Primary outcome
The sustained viral response rate
Time frame: 12 weeks after end of treatment
Qualitative hepatitis C virus RNA polymerase chain reaction
1 secondary outcome
Adverse drug events
Time frame: weeks 2, 4, 8, 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 33930223Dehghan Manshadi SA, Merat S, Mohraz M, Rasoolinejad M, Sali S, Mardani M, Tabarsi P, Somi MH, Sedghi R, Tayeri K, Nikbin M, Karimi J, Sharifi AH, Kalantari S, Norouzi A, Merat D, Malekzadeh Z, Mirminachi B, Poustchi H, Malekzadeh R. Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. Int J Clin Pract. 2021 Aug;75(8):e14304. doi: 10.1111/ijcp.14304. Epub 2021 May 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Malekzadeh study chair
Tehran University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sofosbuvir and daclatasvir in people with Hepatitis C Virus Infection, Response to Therapy of and Human Immunodeficiency Virus, run by Tehran University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sustained viral response rate (time frame: 12 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.