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Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

Primary Purpose

HIV-infection/Aids

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
FNC
3TC
TDF
EFV
FNC placebo
3TC placebo
Sponsored by
HeNan Sincere Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-infection/Aids focused on measuring FNC, HIV-infection, Aids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-65 years old, regardless of gender;
  2. Participant must have an positive HIV test;
  3. Have not received anti-HIV treatment;
  4. HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
  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.

Exclusion Criteria:

  1. History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
  2. Patients with severe opportunistic infection or tumor;
  3. Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
  4. Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
  5. Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
  6. Glomerular filtration rate < 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
  7. Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
  8. History of pancreatitis;
  9. Women in pregnancy and breastfeeding;
  10. History of drug abuse, alcohol abuse and drug abuse;
  11. Participating in clinical trials of other drugs within the first three months of screening;
  12. Other factors considered inappropriate by the investigator to be included in the study

Sites / Locations

  • Beijing YouAn Hospital, Capital Medical University
  • Beijing DiTan Hospital, Capital Medical University
  • Chongqing Public Health Medical Center
  • Guangzhou Eighth People's Hospital
  • Wuhan Jinyintan Hospital
  • The Fouth Hospital of Harbin Medical University
  • The Sixth People's Hospital of Zhengzhou
  • The First Hospital of Changsha
  • The Second Hospital of Nanjing
  • The Public Health Clinical Center of Chengdu
  • Tianjin Second People's Hospital
  • Xixi Hospital of Hangzhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FNC Treatment Group

3TC control group

Arm Description

FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime

3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）
Time to HIV-1 RNA<50 copies/ml from baseline
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
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
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.

Full Information

First Posted
March 4, 2020
Last Updated
March 6, 2020
Sponsor
HeNan Sincere Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04303598
Brief Title
Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HeNan Sincere Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-infection/Aids
Keywords
FNC, HIV-infection, Aids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
The experiment was conducted under a randomized method, each center disputed into the group via competition. Treatment assignment was carried out in accordance with a central randomization schedule generated with SAS (version 9.4). Randomization was done by a computer-generated system (IWRS). The randomization table (1st blind code) and second blind code were sealed and stored in triplicate offices of the sponsor, investigator and the independent statistician.
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FNC Treatment Group
Arm Type
Experimental
Arm Description
FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
Arm Title
3TC control group
Arm Type
Active Comparator
Arm Description
3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
Intervention Type
Drug
Intervention Name(s)
FNC
Other Intervention Name(s)
Azvudine
Intervention Description
3mg, 1 tablet，QD
Intervention Type
Drug
Intervention Name(s)
3TC
Other Intervention Name(s)
Lamivudine
Intervention Description
300mg, 1 tablet，QD
Intervention Type
Drug
Intervention Name(s)
TDF
Other Intervention Name(s)
Tenofovir Fumarate
Intervention Description
300mg, 1 tablet，QD
Intervention Type
Drug
Intervention Name(s)
EFV
Other Intervention Name(s)
Efavirenz
Intervention Description
200mg, 1 tablet，QD
Intervention Type
Drug
Intervention Name(s)
FNC placebo
Other Intervention Name(s)
Azvudine placebo
Intervention Description
1 tablet，QD
Intervention Type
Drug
Intervention Name(s)
3TC placebo
Other Intervention Name(s)
Lamivudine placebo
Intervention Description
1 tablet，QD
Primary Outcome Measure Information:
Title
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
Description
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.
Time Frame
48 Weeks
Secondary Outcome Measure Information:
Title
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 24 and Week 96
Description
Rate of participants with a HIV-1 RNA < 50 copies per mL at Week 24 and Week 96
Time Frame
Week 24 and Week 96
Title
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ，Week 48 and Week 96；
Description
Rate of participants with a HIV-1 RNA < 50 copies per mL at Week 24，Week 48 and Week 96
Time Frame
Week 24 and Week 48 and Week 96,
Title
Change of CD4+ cell count from baseline at Week 48 and Week 96
Description
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
Time Frame
Week 48 and Week 96
Title
Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）
Description
Time to HIV-1 RNA<50 copies/ml from baseline
Time Frame
Baseline and Week 96
Title
Diachronic change of logarithm (log) HIV-RNA reduction from baseline
Description
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
Time Frame
Baseline and Week 96
Title
Diachronic change of CD4+T、 CD8+T cell count from baseline
Description
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
Time Frame
Baseline and Week 96
Title
Safety outcome of subjects at Week 48 and Week 96。
Description
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.
Time Frame
Week 48 and Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Hao
Phone
+86 13601242523
Email
whdoc@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Yuanhao
Phone
+86 13601242523
Email
wanyuanhao@zsswkj.net
Facility Information:
Facility Name
Beijing YouAn Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Hao, MD
Phone
13501253203
Email
whdoc@sina.com
Facility Name
Beijing DiTan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Fujie
Facility Name
Chongqing Public Health Medical Center
City
Chongqing
State/Province
Chongqing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Yaokai
Facility Name
Guangzhou Eighth People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cai Weiping
Facility Name
Wuhan Jinyintan Hospital
City
Wuhan
State/Province
Hebei
Country
China
Facility Name
The Fouth Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengdu Xiaohong
Facility Name
The Sixth People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Qingxia
Facility Name
The First Hospital of Changsha
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Min
Facility Name
The Second Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The Public Health Clinical Center of Chengdu
City
Chengdu
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Shenghua
Facility Name
Tianjin Second People's Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Ping
Facility Name
Xixi Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Jianhua

12. IPD Sharing Statement

Learn more about this trial

Phase III Clinical Study of Azvudine in Hiv-infected Treatment Naive Patients

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