- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04303598
Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
March 6, 2020 updated by: HeNan Sincere Biotech Co., Ltd
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
720
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wu Hao
- Phone Number: +86 13601242523
- Email: whdoc@sina.com
Study Contact Backup
- Name: Wan Yuanhao
- Phone Number: +86 13601242523
- Email: wanyuanhao@zsswkj.net
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Beijing Ditan Hospital, Capital Medical University
-
Contact:
- Zhang Fujie
-
Beijing, Beijing, China, 100001
- Beijing Youan Hospital, Capital Medical University
-
Contact:
- Wu Hao, MD
- Phone Number: 13501253203
- Email: whdoc@sina.com
-
-
Chongqing
-
Chongqing, Chongqing, China
- Chongqing Public Health Medical Center
-
Contact:
- Chen Yaokai
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Guangzhou Eighth People's Hospital
-
Contact:
- Cai Weiping
-
-
Hebei
-
Wuhan, Hebei, China
- Wuhan Jinyintan Hospital
-
-
Heilongjiang
-
Harbin, Heilongjiang, China
- The Fouth Hospital of Harbin Medical University
-
Contact:
- Chengdu Xiaohong
-
-
Henan
-
Zhengzhou, Henan, China
- The Sixth People's Hospital of Zhengzhou
-
Contact:
- Zhao Qingxia
-
-
Hunan
-
Changsha, Hunan, China
- The First Hospital of Changsha
-
Contact:
- Wang Min
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- The Second Hospital of Nanjing
-
-
Sichuan
-
Chengdu, Sichuan, China
- The Public Health Clinical Center Of Chengdu
-
Contact:
- He Shenghua
-
-
Tianjin
-
Tianjin, Tianjin, China
- Tianjin Second People's Hospital
-
Contact:
- Ma Ping
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Xixi hospital of Hangzhou
-
Contact:
- Yu Jianhua
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FNC Treatment Group
FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
|
3mg, 1 tablet,QD
Other Names:
300mg, 1 tablet,QD
Other Names:
200mg, 1 tablet,QD
Other Names:
1 tablet,QD
Other Names:
|
Active Comparator: 3TC control group
3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
|
300mg, 1 tablet,QD
Other Names:
200mg, 1 tablet,QD
Other Names:
300mg, 1 tablet,QD
Other Names:
1 tablet,QD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
48 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 participants with a HIV-1 RNA < 50 copies per mL at Week 24 and Week 96
|
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,
|
Rate of participants with a HIV-1 RNA < 50 copies per mL at Week 24,Week 48 and Week 96
|
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
|
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
|
Week 48 and Week 96
|
Time to achieve virologic failure(HIV-1 RNA<50 copies/ml)
Time Frame: Baseline and Week 96
|
Time to HIV-1 RNA<50 copies/ml from baseline
|
Baseline and Week 96
|
Diachronic change of logarithm (log) HIV-RNA reduction from baseline
Time Frame: Baseline and Week 96
|
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
|
Baseline and Week 96
|
Diachronic change of CD4+T、 CD8+T cell count from baseline
Time Frame: Baseline and Week 96
|
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
|
Baseline and Week 96
|
Safety outcome of subjects at Week 48 and Week 96。
Time Frame: 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.
|
Week 48 and Week 96
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2020
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
March 4, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 11, 2020
Study Record Updates
Last Update Posted (Actual)
March 11, 2020
Last Update Submitted That Met QC Criteria
March 6, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Tenofovir
- Lamivudine
- Efavirenz
Other Study ID Numbers
- GQ-FNC-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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