HIV-infection/AidsPhase 3NCT04303598
Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
A Phase 3 study testing FNC, 3TC and TDF in people with HIV-infection/Aids, run by Henan Genuine Biotech Co., Ltd. at 12 sites in China.
Trial summary
Azvudine,(FNC)， new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-infection/Aids
- What is being tested?
- FNC, 3TC and TDF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 12 sitesChina
- Study dates
- 1 Apr 2020to 1 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old, regardless of gender;
- Participant must have an positive HIV test;
- Have not received anti-HIV treatment;
- HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
- 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;
- 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
- History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
- Patients with severe opportunistic infection or tumor;
- Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
- Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
- Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
- Glomerular filtration rate < 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
Show all 12Show fewer
- Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
- History of pancreatitis;
- Women in pregnancy and breastfeeding;
- History of drug abuse, alcohol abuse and drug abuse;
- Participating in clinical trials of other drugs within the first three months of screening;
- Other factors considered inappropriate by the investigator to be included in the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100001
Wu Hao, MD, 13501253203, whdoc@sina.com
Beijing DiTan Hospital, Capital Medical University
Beijing, Beijing Municipality
Zhang Fujie
The First Hospital of Changsha
Changsha, Hunan
Wang Min
The Public Health Clinical Center of Chengdu
Chengdu, Sichuan
He Shenghua
Chongqing Public Health Medical Center
Chongqing, Chongqing Municipality
Chen Yaokai
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong
Cai Weiping
Xixi Hospital of Hangzhou
Hangzhou, Zhejiang
Yu Jianhua
The Fouth Hospital of Harbin Medical University
Harbin, Heilongjiang
Chengdu Xiaohong
The Second Hospital of Nanjing
Nanjing, Jiangsu
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality
Ma Ping
Wuhan Jinyintan Hospital
Wuhan, Hebei
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan
Zhao Qingxia
About this study
Official title: A Randomized, Double-blind, Double-simulated, Active-controlled，Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients
Azvudine,(FNC)， new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.
- Conditions
- HIV-infection/Aids
- Being tested
- FNC, 3TC, TDF, EFV, FNC placebo
- Keywords
- FNC, HIV-infection, 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.
FNCDrug
Also called Azvudine
3mg, 1 tablet，QD
3TCDrug
Also called Lamivudine
300mg, 1 tablet，QD
TDFDrug
Also called Tenofovir Fumarate
300mg, 1 tablet，QD
EFVDrug
Also called Efavirenz
200mg, 1 tablet，QD
FNC placeboDrug
Also called Azvudine placebo
1 tablet，QD
3TC placeboDrug
Also called Lamivudine placebo
1 tablet，QD
| Study group | Role | What they receive |
|---|---|---|
| FNC Treatment Group | Experimental | FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime Receives: Drug: FNC; Drug: TDF; Drug: EFV; Drug: 3TC placebo |
| 3TC control group | Active comparator | 3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime Receives: Drug: 3TC; Drug: TDF; Drug: EFV; Drug: FNC placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
Rate of participants with a HIV-1 RNA < 50 copies per mL .If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
Measured: 48 Weeks
Secondary outcomes (7)
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 24 and Week 96
Rate of participants with a HIV-1 RNA < 50 copies per mL at Week 24 and Week 96
Measured: Week 24 and Week 96
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ，Week 48 and Week 96；
Rate of participants with a HIV-1 RNA < 50 copies per mL at Week 24，Week 48 and Week 96
Measured: Week 24 and Week 48 and Week 96,
Change of CD4+ cell count from baseline at Week 48 and Week 96
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 48 and 96 were assessed
Measured: Week 48 and Week 96
Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）
Time to HIV-1 RNA<50 copies/ml from baseline
Measured: Baseline and Week 96
Diachronic change of logarithm (log) HIV-RNA reduction from baseline
The Diachronic change of logarithm (log) HIV-RNA change was determined by changes in Cluster of logarithm (log) HIV-RNA count. Change from baseline in logarithm (log) HIV-RNA at Weeks 96 were assessed
Measured: Baseline and Week 96
Diachronic change of CD4+T、 CD8+T cell count from baseline
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count to Weeks 96 were assessed
Measured: Baseline and Week 96
Safety outcome of subjects at Week 48 and Week 96。
Rate of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Week 48 and Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infection/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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303598
- Sponsor's protocol ID
- GQ-FNC-301
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-simulated, Active-controlled，Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients
- ClinicalTrials.gov ID
- NCT04303598
- Acronym / sponsor ID
- GQ-FNC-301
- Conditions
- HIV-infection/Aids
- Keywords
- FNC, HIV-infection, Aids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 11 Mar 2020 (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.
Azvudine,(FNC)， new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNC Treatment Group | Experimental | Drug: FNC, Drug: TDF, Drug: EFV, Drug: 3TC placeboFNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime |
| 3TC control group | Active comparator | Drug: 3TC, Drug: TDF, Drug: EFV, Drug: FNC placebo3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-65 years old, regardless of gender;
- Participant must have an positive HIV test;
- Have not received anti-HIV treatment;
- HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
- 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;
Key exclusion criteria (12 listed)
- History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
- Patients with severe opportunistic infection or tumor;
- Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
- Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
- Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
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 |
|---|---|---|
| FNCAlso: Azvudine3mg, 1 tablet，QD | Drug | FNC Treatment Group |
| 3TCAlso: Lamivudine300mg, 1 tablet，QD | Drug | 3TC control group |
| TDFAlso: Tenofovir Fumarate300mg, 1 tablet，QD | Drug | 3TC control group, FNC Treatment Group |
| EFVAlso: Efavirenz200mg, 1 tablet，QD | Drug | 3TC control group, FNC Treatment Group |
| FNC placeboAlso: Azvudine placebo1 tablet，QD | Drug | 3TC control group |
| 3TC placeboAlso: Lamivudine placebo1 tablet，QD | Drug | FNC Treatment Group |
Primary outcome
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
Time frame: 48 Weeks
Rate of participants with a HIV-1 RNA < 50 copies per mL .If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
7 secondary outcomes
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 24 and Week 96
Time frame: Week 24 and Week 96
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ，Week 48 and Week 96；
Time frame: Week 24 and Week 48 and Week 96,
Change of CD4+ cell count from baseline at Week 48 and Week 96
Time frame: Week 48 and Week 96
Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）
Time frame: Baseline and Week 96
Diachronic change of logarithm (log) HIV-RNA reduction from baseline
Time frame: Baseline and Week 96
Diachronic change of CD4+T、 CD8+T cell count from baseline
Time frame: Baseline and Week 96
Safety outcome of subjects at Week 48 and Week 96。
Time frame: Week 48 and Week 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Related trials for HIV-infection/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)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
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.
12 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 FNC, 3TC and TDF in people with HIV-infection/Aids, run by Henan Genuine Biotech Co., Ltd. at 12 sites in China.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Hao (+86 13601242523, whdoc@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48 (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2020.