AIDSPhase 2FNCNCT04109183

A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV Treatment

A Phase 2 study testing The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF. in people with AIDS, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective of this trial was to evaluate the safety and preliminary evaluation of Azvudine tablets (FNC) in combination with reverse transcriptase inhibitors therapy in treatment-naive patients with HIV infection.; the secondary objective is to explore the effective dose of clinical use of Azvudine (FNC)… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: AIDS
What is being tested?: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: 1 siteChina
Study dates: 10 Oct 2017to 6 Mar 2019
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1.18-65 years old, regardless of gender; 2.Confirmed HIV positive with a report; 3.Have not received anti-hiv antiviral treatment; 4.HIV viral load ≥1000 copies/mL; 5.Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration; 6.The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent.

Who cannot join

Patients who have received anti-HIV treatment;
Suffering from a serious opportunistic infection or opportunistic tumor;
Abnormal blood routine examination (white blood cells <3 × 109 / L, hemoglobin <90g / L, neutrophils <1.5 × 109 / L, platelets <75 × 109 / L);
Have a definite liver disease (hepatitis B surface antigen/HCV antibody positive), or abnormal liver function test (alanine aminotransferase and/or aspartate aminotransferase exceeds the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value 2 times);
Renal insufficiency (glomerular filtration rate <70ml/min, or creatinine above the upper limit of normal);
Now suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases;

Show all 12Show fewer

Has suffered from pancreatitis;
Women during pregnancy and lactation;
allergic constitution or known to be allergic to the pharmaceutical ingredients and the basic drugs prescribed in this program;
Suspect or determine the history of alcohol and drug abuse;
Participated in other drug clinical trials (excluding Chinese medicine) within the first three months of screening;
Other factors that are not suitable for entering the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing YouAn Hospital, Capital Medical University.
Beijing, Beijing Municipality, 10000

Other trials in China

About this study

Official title: A Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV treatment--a Multicenter, Randomized, Double-blind, Double-simulation, Positive Control Trial

Read the detailed description

Azvudine (FNC), a new class I drug with independent intellectual property rights, is a novel nucleoside reverse transcriptase inhibitor with good inhibitory activity against HIV-1 and obtained the National Medical Products Administration(NMPA) approved for clinical research.

In this trial, 172 patients who had not received anti-HIV treatment were enrolled, including FNC4mg group, FNC3mg group, FNC2mg group, and 3TC control group, 43 cases, 5 research centers, and each research center was simultaneously engaged and competing. The enrolled subjects underwent 7 visits including baseline visits, and HIV -1RNA and CD4 cell counts were tested and statistically analyzed for each visit.

Conditions: AIDS
Being tested: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Keywords: HIV/AIDS
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.Drug
The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.

Study groups in NCT04109183
Study group	Role	What they receive
Active Comparator: FNC 2 mg+ TDF+EFV	Experimental	Not described Receives: Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Active Comparator: FNC 3 mg+ TDF+EFV	Experimental	Not described Receives: Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Active Comparator: FNC 4 mg+ TDF+EFV	Experimental	Not described Receives: Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Postive Comparator: 3TC+ TDF+EFV	Experimental	Not described Receives: Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of azivudine tablet (FNC) combined with reverse transcriptase inhibitor therapy without anti-hiv treatment.
Number of subjects with HIV viral load < 50copies/ml after treatment
Measured: At 48 weeks
Preliminary evaluation of the efficacy of azivudine tablets (FNC) combined with reverse transcriptase inhibitors in the treatment of patients who have not received anti-hiv treatment.
Number of subjects with HIV viral load < 50copies/ml after treatment
Measured: At 48 weeks

Secondary outcomes (1)

To explore the effective dose of azivudine tablet (FNC) in clinic
Changes in HIV load logarithm before and after treatment, including the number of subjects whose HIV load level decreased by ≥1log from baseline before and after treatment;CD4 cell count before and after treatment
Measured: At 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 20176 Mar 2019

First posted30 Sep 2019
Study start10 Oct 2017
Primary completion28 Jan 2019
Study completion6 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AIDSStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: a multicenter, randomized, double-blind, double-simulation, positive control trial.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04109183
Sponsor's protocol ID: GQ-FNC-201
Acronym: FNC
Status last verified: Sep 2019
First submitted: 25 Sep 2019
Last updated: 30 Sep 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV treatment--a Multicenter, Randomized, Double-blind, Double-simulation, Positive Control Trial
ClinicalTrials.gov ID: NCT04109183
Acronym / sponsor ID: FNC / GQ-FNC-201
Conditions: AIDS
Keywords: HIV/AIDS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Beijing YouAn Hospital, Peking Union Medical College Hospital, Beijing Ditan Hospital, Guangzhou 8th People's Hospital, The Sixth People's Hospital of Zhengzhou
Study start: 10 Oct 2017 (actual)
Primary completion: 28 Jan 2019 (actual)
Study completion: 6 Mar 2019 (actual)
First posted: 30 Sep 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4
Model description: a multicenter, randomized, double-blind, double-simulation, positive control trial.

Arm	Type	Receives
Active Comparator: FNC 2 mg+ TDF+EFV	Experimental	Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Active Comparator: FNC 3 mg+ TDF+EFV	Experimental	Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Active Comparator: FNC 4 mg+ TDF+EFV	Experimental	Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
Postive Comparator: 3TC+ TDF+EFV	Experimental	Drug: The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1.18-65 years old, regardless of gender; 2.Confirmed HIV positive with a report; 3.Have not received anti-hiv antiviral treatment; 4.HIV viral load ≥1000 copies/mL; 5.Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration; 6.The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent.

Key exclusion criteria (12 listed)

Patients who have received anti-HIV treatment;
Suffering from a serious opportunistic infection or opportunistic tumor;
Abnormal blood routine examination (white blood cells <3 × 109 / L, hemoglobin <90g / L, neutrophils <1.5 × 109 / L, platelets <75 × 109 / L);
Have a definite liver disease (hepatitis B surface antigen/HCV antibody positive), or abnormal liver function test (alanine aminotransferase and/or aspartate aminotransferase exceeds the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value 2 times);
Renal insufficiency (glomerular filtration rate <70ml/min, or creatinine above the upper limit of normal);

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
The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.	Drug	Active Comparator: FNC 2 mg+ TDF+EFV, Active Comparator: FNC 3 mg+ TDF+EFV, Active Comparator: FNC 4 mg+ TDF+EFV, Postive Comparator: 3TC+ TDF+EFV

Primary outcome

Evaluation of azivudine tablet (FNC) combined with reverse transcriptase inhibitor therapy without anti-hiv treatment.
Time frame: At 48 weeks
Number of subjects with HIV viral load < 50copies/ml after treatment
Preliminary evaluation of the efficacy of azivudine tablets (FNC) combined with reverse transcriptase inhibitors in the treatment of patients who have not received anti-hiv treatment.
Time frame: At 48 weeks
Number of subjects with HIV viral load < 50copies/ml after treatment

1 secondary outcome

To explore the effective dose of azivudine tablet (FNC) in clinic
Time frame: At 48 weeks

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 30 Sep 2019.
Individual participant dataSharing planned: No

Related trials for AIDS

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 12 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Evaluation of azivudine tablet (FNC) combined with reverse transcriptase inhibitor therapy without anti-hiv treatment. (time frame: At 48 weeks). The study lists 2 primary outcomes in all. 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 NCT04109183.

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 30 Sep 2019.